Subcutaneous electrode with improved contact shape for transthoracic conduction

ABSTRACT

One embodiment of the present invention provides a lead electrode assembly for use with an implantable cardioverter-defibrillator subcutaneously implanted outside the ribcage between the third and eighth ribs comprising an electrode.

BACKGROUND OF THE INVENTION

[0001] Defibrillation/cardioversion is a technique employed to counterarrhythmic heart conditions including some tachycardias in the atriaand/or ventricles. Typically, electrodes are employed to stimulate theheart with electrical impulses or shocks, of a magnitude substantiallygreater than pulses used in cardiac pacing.

[0002] Defibrillation/cardioversion systems include body implantableelectrodes and are referred to as implantablecardioverter/defibrillators (ICDs). Such electrodes can be in the formof patches applied directly to epicardial tissue, or at the distal endregions of intravascular catheters, inserted into a selected cardiacchamber. U.S. Pat. Nos. 4,603,705, 4,693,253, 4,944,300, 5,105,810, thedisclosures of which are all incorporated herein by reference, discloseintravascular or transvenous electrodes, employed either alone or incombination with an epicardial patch electrode. Compliant epicardialdefibrillator electrodes are disclosed in U.S. Pat. Nos. 4,567,900 and5,618,287, the disclosures of which are incorporated herein byreference. A sensing epicardial electrode configuration is disclosed inU.S. Pat No. 5,476,503, the disclosure of which is incorporated hereinby reference.

[0003] In addition to epicardial and transvenous electrodes,subcutaneous electrode systems have also been developed. For example,U.S. Pat. Nos. 5,342,407 and 5,603,732, the disclosures of which areincorporated herein by reference, teach the use of a pulsemonitor/generator surgically implanted into the abdomen and subcutaneouselectrodes implanted in the thorax. This system is far more complicatedto use than current ICD systems using transvenous lead systems togetherwith an active can electrode and therefore it has o practical use. Ithas in fact never been used because of the surgical difficulty ofapplying such a device (3 incisions), the impractical abdominal locationof the generator and the electrically poor sensing and defibrillationaspects of such a system.

[0004] Recent efforts to improve the efficiency of ICDs have ledmanufacturers to produce ICDs which are small enough to be implanted inthe pectoral region. In addition, advances in circuit design haveenabled the housing of the ICD to form a subcutaneous electrode. Someexamples of ICDs in which the housing of the ICD serves as an optionaladditional electrode are described in U.S. Pat. Nos. 5,133,353,5,261,400, 5,620,477, and 5,658,321 the disclosures of which areincorporated herein by reference.

[0005] ICDs are now an established therapy for the management of lifethreatening cardiac rhythm disorders, primarily ventricular fibrillation(V-Fib). ICDs are very effective at treating V-Fib, but are therapiesthat still require significant surgery.

[0006] As ICD therapy becomes more prophylactic in nature and used inprogressively less ill individuals, especially children at risk ofcardiac arrest, the requirement of ICD therapy to use intravenouscatheters and transvenous leads is an impediment to very long termmanagement as most individuals will begin to develop complicationsrelated to lead system malfunction sometime in the 5-10 year time frame,often earlier. In addition, chronic transvenous lead systems, theirreimplantation and removals, can damage major cardiovascular venoussystems and the tricuspid valve, as well as result in life threateningperforations of the great vessels and heart. Consequently, use oftransvenous lead systems, despite their many advantages, are not withouttheir chronic patient management limitations in those with lifeexpectancies of >5 years. The problem of lead complications is evengreater in children where body growth can substantially altertransvenous lead function and lead to additional cardiovascular problemsand revisions. Moreover, transvenous ICD systems also increase cost andrequire specialized interventional rooms and equipment as well asspecial skill for insertion. These systems are typically implanted bycardiac electrophysiologists who have had a great deal of extratraining.

[0007] In addition to the background related to ICD therapy, the presentinvention requires a brief understanding of automatic externaldefibrillator (AED) therapy. AEDs employ the use of cutaneous patchelectrodes to effect defibrillation under the direction of a bystanderuser who treats the patient suffering from V-Fib. AEDs can be aseffective as an ICD if applied to the victim promptly within 2 to 3minutes.

[0008] AED therapy has great appeal as a tool for diminishing the riskof death in public venues such as in air flight. However, an AED must beused by another individual, not the person suffering from the potentialfatal rhythm. It is more of a public health tool than a patient-specifictool like an ICD. Because >75% of cardiac arrests occur in the home, andover half occur in the bedroom, patients at risk of cardiac arrest areoften alone or asleep and can not be helped in time with an AED.Moreover, its success depends to a reasonable degree on an acceptablelevel of skill and calm by the bystander user.

[0009] What is needed therefore, especially for children and forprophylactic long term use, is a combination of the two forms of therapywhich would provide prompt and near-certain defibrillation, like an ICD,but without the long-term adverse sequelae of a transvenous lead systemwhile simultaneously using most of the simpler and lower cost technologyof an AED. What is also needed is a cardioverter/defibrillator that isof simple design and can be comfortably implanted in a patient for manyyears.

SUMMARY OF THE INVENTION

[0010] One embodiment of the present invention provides a lead electrodeassembly for use with an implantable cardioverter-defibrillatorsubcutaneously implanted outside the ribcage between the third andeighth ribs comprising an electrode.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] For a better understanding of the invention, reference is nowmade to the drawings where like numerals represent similar objectsthroughout the figures where:

[0012]FIG. 1 is a schematic view of a Subcutaneous ICD (S-ICD) of thepresent invention;

[0013]FIG. 2 is a schematic view of an alternate embodiment of asubcutaneous electrode of the present invention;

[0014]FIG. 3 is a schematic view of an alternate embodiment of asubcutaneous electrode of the present invention;

[0015]FIG. 4 is a schematic view of the S-ICD and lead of FIG. 1subcutaneously implanted in the thorax of a patient;

[0016]FIG. 5 is a schematic view of the S-ICD and lead of FIG. 2subcutaneously implanted in an alternate location within the thorax of apatient;

[0017]FIG. 6 is a schematic view of the S-ICD and lead of FIG. 3subcutaneously implanted in the thorax of a patient;

[0018]FIG. 7 is a schematic view of the method of making a subcutaneouspath from the preferred incision and housing implantation point to atermination point for locating a subcutaneous electrode of the presentinvention;

[0019]FIG. 8 is a schematic view of an introducer set for performing themethod of lead insertion of any of the described embodiments;

[0020]FIG. 9 is a schematic view of an alternative S-ICD of the presentinvention illustrating a lead subcutaneously and serpiginously implantedin the thorax of a patient for use particularly in children;

[0021]FIG. 10 is a schematic view of an alternate embodiment of an S-ICDof the present invention;

[0022]FIG. 11 is a schematic view of the S-ICD of FIG. 10 subcutaneouslyimplanted in the thorax of a patient;

[0023]FIG. 12 is a schematic view of yet a further embodiment where thecanister of the S-ICD of the present invention is shaped to beparticularly useful in placing subcutaneously adjacent and parallel to arib of a patient; and

[0024]FIG. 13 is a schematic of a different embodiment where thecanister of the S-ICD of the present invention is shaped to beparticularly useful in placing subcutaneously adjacent and parallel to arib of a patient.

[0025]FIG. 14 is a schematic view of a Unitary Subcutaneous ICD (US-ICD)of the present invention;

[0026]FIG. 15 is a schematic view of the US-ICD subcutaneously implantedin the thorax of a patient;

[0027]FIG. 16 is a schematic view of the method of making a subcutaneouspath from the preferred incision for implanting the US-ICD.

[0028]FIG. 17 is a schematic view of an introducer for performing themethod of US-ICD implantation; and

[0029]FIG. 18 is an exploded schematic view of an alternate isembodiment of the present invention with a plug-in portion that containsoperational circuitry and means for generatingcardioversion/defibrillation shock waves.

[0030]FIG. 14(a) is a side plan view of an embodiment of a leadelectrode assembly with a top-mounted fin;

[0031]FIG. 14(b) is a top plan view of an embodiment of a lead electrodeassembly with a top-mounted fin;

[0032]FIG. 14(c) is a side plan view of a section of the lead in anembodiment of the lead electrode assembly;

[0033]FIG. 14(d) is a cross-sectional view of a filar in the lead in anembodiment of the lead electrode assembly;

[0034]FIG. 14(e) is a cross-sectional view of the lead fastener of anembodiment of a lead electrode assembly;

[0035]FIG. 14(f) is an exploded view of the lead fastener of anembodiment of a lead electrode assembly;

[0036]FIG. 15(a) is a cross-sectional front plan view of an embodimentof a lead electrode assembly with a top-mounted fin;

[0037]FIG. 15(b) is a top plan view of an embodiment of a lead electrodeassembly with a top-mounted fin;

[0038]FIG. 16(a) is a perspective view of an embodiment of a leadelectrode assembly with a top-mounted fin;

[0039]FIG. 17(a) is a cross-sectional side plan view of an embodiment ofa lead electrode assembly with a top-mounted fin and a molded cover;

[0040]FIG. 17(b) is a cross-sectional side plan view of an embodiment ofa lead electrode assembly with a top-mounted fin that is slope-shapedand a molded cover;

[0041]FIG. 17(c) is cross-sectional front plan view of an embodiment ofa lead electrode assembly with a top-mounted fin and a molded cover;

[0042]FIG. 17(d) is an exploded top plan view of the lead fastener in anembodiment of a lead electrode assembly with a top-mounted fin and amolded cover;

[0043]FIG. 17(e) is a bottom plan view of an embodiment of a leadelectrode assembly with a top-mounted fin and a molded cover;

[0044]FIG. 17(f) is a side plan view of an embodiment of a leadelectrode assembly with a top-mounted fin and a molded cover;

[0045]FIG. 17(g) is a top plan view of an embodiment of a lead electrodeassembly with a top-mounted fin and a molded cover;

[0046]FIG. 18(a) is a side plan view of an embodiment of a leadelectrode assembly with an elongated top-mounted fin and a molded cover;

[0047]FIG. 18(b) is a top plan view of an embodiment of a lead electrodeassembly with an elongated top-mounted fin and a molded cover;

[0048]FIG. 18(c) is a bottom plan view of an embodiment of a leadelectrode assembly with an elongated top-mounted fin and a molded cover;

[0049]FIG. 19 is a side plan view of a lead electrode assemblydemonstrating the curvature of the electrode;

[0050]FIG. 20(a) is a top plan view of the backing layer and electrodeof an embodiment of a lead electrode assembly with a side-mounted fin;

[0051]FIG. 20(b) is a side plan view of the backing layer and electrodeof an embodiment of a lead electrode assembly with a side-mounted fin;

[0052]FIG. 20(c) is a bottom plan view of an embodiment of a leadelectrode assembly with a side-mounted fin;

[0053]FIG. 20(d) is a bottom plan view of an embodiment of a leadelectrode assembly with a side-mounted fin with a slope-shape;

[0054]FIG. 21(a) is a side plan view of a lead electrode assembly with atop-mounted loop;

[0055]FIG. 21(b) is a cross-sectional rear plan view of a lead electrodeassembly with a top-mounted loop;

[0056]FIG. 21(c) is a top plan view of a lead electrode assembly with atop-mounted loop;

[0057]FIG. 22(a) is a top plan view of a backing layer for use in anembodiment of a lead electrode assembly with a top-mounted fin formed aspart of the backing layer;

[0058]FIG. 22(b) is a top plan view of an embodiment of a lead electrodeassembly with a top-mounted fin formed as part of the backing layer;

[0059]FIG. 22(c) is a side plan view of an embodiment of a leadelectrode assembly with a top-mounted fin formed as part of the backinglayer;

[0060]FIG. 22(d) is a front plan view of an embodiment of a leadelectrode assembly with a top-mounted fin formed as part of a backinglayer;

[0061]FIG. 22(e) is a side plan view of an embodiment of a leadelectrode assembly with a top-mounted fin formed as part of a two-piecebacking layer;

[0062]FIG. 22(f) is a front plan view of an embodiment of a leadelectrode assembly with a top-mounted fin formed as part of a two-piecebacking layer;

[0063]FIG. 23(a) is a front plan view of the embodiment of the leadelectrode assembly of FIG. 22(e) and (f) in an upright position;

[0064]FIG. 23(b) is a front plan view of the embodiment of the leadelectrode assembly of FIG. 22(e) and (f) illustrating the ability of thefin to fold;

[0065]FIG. 24(a) is a front plan view of an embodiment of a leadelectrode assembly with a top-mounted tube formed as part of a backinglayer;

[0066]FIG. 24(b) is a side plan view of an embodiment of a leadelectrode assembly with a top-mounted tube formed as part of a backinglayer;

[0067]FIG. 24(c) is a top plan view of an embodiment of a lead electrodeassembly with a top-mounted tube formed as part of a backing layer;

[0068]FIG. 25(a) is a front plan view of an embodiment of a leadelectrode assembly with a top-mounted fin connected with flexiblejoining material in an upright position;

[0069]FIG. 25(b) is a front plan view of an embodiment of a leadelectrode assembly with a top-mounted fin connected with flexiblejoining material in a folded position;

[0070]FIG. 25(c) is a top plan view of an embodiment of a lead electrodeassembly with a top-mounted fin connected with flexible joining materialin an upright position;

[0071]FIG. 26 is a perspective view of an embodiment of a lead electrodeassembly in which the appendage is a cylindrical tube;

[0072]FIG. 27 is a perspective view of an embodiment of a lead electrodeassembly in which the appendage is a tube with a substantiallytriangular cross section;

[0073] FIGS. 28(a)-(d) are top plan views of embodiments of leadelectrode assemblies illustrating shapes of the electrode and the linesof the lead;

[0074] FIGS. 28(e)-(h) are bottom plan views of embodiments of leadelectrode assemblies illustrating shapes of the electrode;

[0075]FIG. 29 is a perspective view of a custom hemostat for leadelectrode assembly implantation;

[0076]FIG. 30(a) is a perspective view of a patient's ribcage showingthe orientation of the components in an implanted S-ICD system;

[0077]FIG. 30(b) is a cross-sectional side plan view of a patient's ribcage, skin, fat and the lead of the lead electrode assembly;

[0078]FIG. 31 is a front plan view illustrating the incision point forthe surgery to implant the lead electrode assembly;

[0079]FIG. 32(a) is a cross-sectional bottom plan view of a patientalong line 32(a) of FIG. 31 illustrating the creation of a subcutaneouspath for implantation of the lead electrode assembly of an S-ICD system;

[0080]FIG. 32(b) is a perspective view of a lead electrode assemblycaptured by a custom hemostat;

[0081]FIG. 32(c) is a cross-sectional bottom plan view of a patientalong line 32(a) of FIG. 31 illustrating the implantation of a leadelectrode assembly via the subcutaneous path;

[0082]FIG. 32(d) is a top view of a lead electrode assembly captured bya custom hemostat;

[0083]FIG. 33(a) is a perspective view of a rail of an embodiment of thelead electrode assembly;

[0084]FIG. 33(b) is a cross-sectional front plan view of an embodimentof the lead electrode assembly where the appendage is a rail;

[0085]FIG. 33(c) is a top plan view of an embodiment of the leadelectrode assembly where the appendage is a rail;

[0086]FIG. 34 is a top view of an embodiment of the lead electrodeassembly where the appendage is a rail;

[0087]FIG. 35(a) is a perspective view of a lead electrode assemblymanipulation tool with a rail fork;

[0088]FIG. 35(b) is a top plan view of a lead electrode assemblymanipulation tool with a rail fork;

[0089]FIG. 35(c) is a side plan view of a lead electrode assemblymanipulation tool with a rail fork;

[0090]FIG. 35(d) is a top plan view of a lead electrode assembly havinga rail captured by a lead electrode assembly manipulation tool with arail fork;

[0091]FIG. 36(a) is a cross-sectional side plan view of a lead electrodeassembly with a pocket;

[0092]FIG. 36(b) is a top plan view of a lead electrode assembly with apocket;

[0093]FIG. 36(c) is a cross-sectional side plan view of a lead electrodeassembly with a pocket and a fin;

[0094]FIG. 37(a) is a bottom plan view of a lead electrode assembly witha pocket;

[0095]FIG. 37(b) is a top plan view of a lead electrode assembly with apocket;

[0096]FIG. 38(a) is a top plan view of a lead electrode assemblymanipulation tool with a paddle;

[0097]FIG. 38(b) is a side plan view of a lead electrode assemblymanipulation tool with a paddle;

[0098]FIG. 38(c) is a top plan view of a lead electrode assembly with apocket captured by a lead electrode assembly manipulation tool with apaddle;

[0099]FIG. 39(a) is a cross-sectional rear plan view of a lead electrodeassembly with a first channel guide and a second channel guide;

[0100]FIG. 39(b) is a top plan view of a lead electrode assembly with afirst channel guide and a second channel guide;

[0101]FIG. 40(a) is a top plan view of a lead electrode assemblymanipulation tool with a channel guide fork;

[0102]FIG. 40(b) is a top plan view of a lead electrode assembly with afirst channel guide and a second channel guide captured by a leadelectrode assembly manipulation tool with a channel guide fork;

[0103]FIG. 41(a) is a perspective view of a subcutaneous implantablecardioverter-defibrillator kit; and

[0104]FIG. 41(b) is a perspective view of a hemostat illustrating thelength measurement.

DETAILED DESCRIPTION

[0105] Turning now to FIG. 1, the S-ICD of the present invention isillustrated. The S-ICD consists of an electrically active canister 11and a subcutaneous electrode 13 attached to the canister. The canisterhas an electrically active surface 15 that is electrically insulatedfrom the electrode connector block 17 and the canister housing 16 viainsulating area 14. The canister can be similar to numerous electricallyactive canisters commercially available in that the canister willcontain a battery supply, capacitor and operational circuitry.Alternatively, the canister can be thin and elongated to conform to theintercostal space. The circuitry will be able to monitor cardiac rhythmsfor tachycardia and fibrillation, and if detected, will initiatecharging the capacitor and then delivering cardioversion/defibrillationenergy through the active surface of the housing and to the subcutaneouselectrode. Examples of such circuitry are described in U.S. Pat. Nos.4,693,253 and 5,105,810, the entire disclosures of which are hereinincorporated by reference. The canister circuitry can providecardioversion/defibrillation energy in different types of waveforms. Inthe preferred embodiment, a 100 uF biphasic waveform is used ofapproximately 10-20 ms total duration and with the initial phasecontaining approximately ⅔ of the energy, however, any type of waveformcan be utilized such as monophasic, biphasic, multiphasic or alternativewaveforms as is known in the art.

[0106] In addition to providing cardioversion/defibrillation energy, thecircuitry can also provide transthoracic cardiac pacing energy. Theoptional circuitry will be able to monitor the heart for bradycardiaand/or tachycardia rhythms. Once a bradycardia or tachycardia rhythm isdetected, the circuitry can then deliver appropriate pacing energy atappropriate intervals through the active surface and the subcutaneouselectrode. Pacing stimuli will be biphasic in the preferred embodimentand similar in pulse amplitude to that used for conventionaltransthoracic pacing.

[0107] This same circuitry can also be used to deliver low amplitudeshocks on the T-wave for induction of ventricular fibrillation fortesting S-ICD performance in treating V-Fib as is described in U.S. Pat.No. 5,129,392, the entire disclosure of which is hereby incorporated byreference. Also the circuitry can be provided with rapid induction ofventricular fibrillation or ventricular tachycardia using rapidventricular pacing. Another optional way for inducing ventricularfibrillation would be to provide a continuous low voltage, i.e., about 3volts, across the heart during the entire cardiac cycle.

[0108] Another optional aspect of the present invention is that theoperational circuitry can detect the presence of atrial fibrillation asdescribed in Olson, W. et al. “Onset And Stability For VentricularTachyarrhythmia Detection in an Implantable Cardioverter andDefibrillator,” Computers in Cardiology (1986) pp. 167-170. Detectioncan be provided via R-R Cycle length instability detection algorithms.Once a trial fibrillation has been detected, the operational circuitrywill then provide QRS synchronized atrial defibrillation/cardioversionusing the same shock energy and waveshape characteristics used forventricular defibrillation/cardioversion.

[0109] The sensing circuitry will utilize the electronic signalsgenerated from the heart and will primarily detect QRS waves. In oneembodiment, the circuitry will be programmed to detect only ventriculartachycardias or fibrillations. The detection circuitry will utilize inits most direct form, a rate detection algorithm that triggers chargingof the capacitor once the ventricular rate exceeds some predeterminedlevel for a fixed period of time: for example, if the ventricular rateexceeds 240 bpm on average for more than 4 seconds. Once the capacitoris charged, a confirmatory rhythm check would ensure that the ratepersists for at least another 1 second before discharge. Similarly,termination algorithms could be instituted that ensure that a rhythmless than 240 bpm persisting for at least 4 seconds before the capacitorcharge is drained to an internal resistor. Detection, confirmation andtermination algorithms as are described above and in the art can bemodulated to increase sensitivity and specificity by examining QRSbeat-to-beat uniformity, QRS signal frequency content, R-R intervalstability data, and signal amplitude characteristics all or part ofwhich can be used to increase or decrease both sensitivity andspecificity of S-ICD arrhythmia detection function.

[0110] In addition to use of the sense circuitry for detection of V-Fibor V-Tach by examining the QRS waves, the sense circuitry can check forthe presence or the absence of respiration. The respiration rate can bedetected by monitoring the impedance across the thorax usingsubthreshold currents delivered across the active can and the highvoltage subcutaneous lead electrode and monitoring the frequency inundulation in the waveform that results from the undulations oftransthoracic impedance during the respiratory cycle. If there is noundulation, then the patent is not respiring and this lack ofrespiration can be used to confirm the QRS findings of cardiac arrest.The same technique can be used to provide information about therespiratory rate or estimate cardiac output as described in U.S. Pat.Nos. 6,095,987, 5,423,326, 4,450,527, the entire disclosures of whichare incorporated herein by reference.

[0111] The canister of the present invention can be made out of titaniumalloy or other presently preferred electrically active canister designs.However, it is contemplated that a malleable canister that can conformto the curvature of the patient's chest will be preferred. In this waythe patient can have a comfortable canister that conforms to the shapeof the patient's rib cage. Examples of conforming canisters are providedin U.S. Pat. No. 5,645,586, the entire disclosure of which is hereinincorporated by reference. Therefore, the canister can be made out ofnumerous materials such as medical grade plastics, metals, and alloys.In the preferred embodiment, the canister is smaller than 60 cc volumehaving a weight of less than 100 gms for long term wearability,especially in children. The canister and the lead of the S-ICD can alsouse fractal or wrinkled surfaces to increase surface area to improvedefibrillation capability. Because of the primary prevention role of thetherapy and the likely need to reach energies over 40 Joules, a featureof the preferred embodiment is that the charge time for the therapy,intentionally e relatively long to allow capacitor charging within thelimitations of device size. Examples of small ICD housings are disclosedin U.S. Pat. Nos. 5,597,956 and 5,405,363, the entire disclosures ofwhich are herein incorporated by reference.

[0112] Different subcutaneous electrodes 13 of the present invention areillustrated in FIGS. 1-3. Turning to FIG. 1, the lead 21 for thesubcutaneous electrode is preferably composed of silicone orpolyurethane insulation. The electrode is connected to the canister atits proximal end via connection port 19 which is located on anelectrically insulated area 17 of the canister. The electrodeillustrated is a composite electrode with three different electrodesattached to the lead. In the embodiment illustrated, an optional anchorsegment 52 is attached at the most distal end of the subcutaneouselectrode for anchoring the electrode into soft tissue such that theelectrode does not dislodge after implantation.

[0113] The most distal electrode on the composite subcutaneous electrodeis a coil electrode 27 that is used for delivering the high voltagecardioversion/defibrillation energy across the heart. The coilcardioversion/defibrillation electrode is about 5-10 cm in length.Proximal to the coil electrode are two sense electrodes, a first senseelectrode 25 is located proximally to the coil electrode and a secondsense electrode 23 is located proximally to the first sense electrode.The sense electrodes are spaced far enough apart to be able to have goodQRS detection. This spacing can range from 1 to 10 cm with 4 cm beingpresently preferred. The electrodes may or may not be circumferentialwith the preferred embodiment. Having the electrodes non-circumferentialand positioned outward, toward the skin surface, is a means to minimizemuscle artifact and enhance QRS signal quality. The sensing electrodesare electrically isolated from the cardioversion/defibrillationelectrode via insulating areas 29. Similar types ofcardioversion/defibrillation electrodes are currently commerciallyavailable in a transvenous configuration. For example, U.S. Pat. No.5,534,022, the entire disclosure of which is herein incorporated byreference, disclosures a composite electrode with a coilcardioversion/defibrillation electrode and sense electrodes.Modifications to this arrangement is contemplated within the scope ofthe invention. One such modification is illustrated in FIG. 2 where thetwo sensing electrodes 25 and 23 are non-circumferential sensingelectrodes and one is located at the distal end, the other is locatedproximal thereto with the coil electrode located in between the twosensing electrodes. In this embodiment the sense electrodes are spacedabout 6 to about 12 cm apart depending on the length of the coilelectrode used. FIG. 3 illustrates yet a further embodiment where thetwo sensing electrodes are located at the distal end to the compositeelectrode with the coil electrode located proximally thereto. Otherpossibilities exist and are contemplated within the present invention.For example, having only one sensing electrode, either proximal ordistal to the coil cardioversion/defibrillation electrode with the coilserving as both a sensing electrode and a cardioversion/defibrillationelectrode.

[0114] It is also contemplated within the scope of the invention thatthe sensing of QRS waves (and transthoracic impedance) can be carriedout via sense electrodes on the canister housing or in combination withthe cardioversion/defibrillation coil electrode and/or the subcutaneouslead sensing electrode(s). In this way, sensing could be performed viathe one coil electrode located on the subcutaneous electrode and theactive surface on the canister housing. Another possibility would be tohave only one sense electrode located on the subcutaneous electrode andthe sensing would be performed by that one electrode and either the coilelectrode on the subcutaneous electrode or by the active surface of thecanister. The use of sensing electrodes on the canister would eliminatethe need for sensing electrodes on the subcutaneous electrode. It isalso contemplated that the subcutaneous electrode would be provided withat least one sense electrode, the canister with at least one senseelectrode, and if multiple sense electrodes are used on either thesubcutaneous electrode and/or the canister, that the best QRS wavedetection combination will be identified when the S-ICD is implanted andthis combination can be selected, activating the best sensingarrangement from all the existing sensing possibilities. Turning againto FIG. 2, two sensing electrodes 26 and 28 are located on theelectrically active surface 15 with electrical insulator rings 30 placedbetween the sense electrodes and the active surface. These canistersense electrodes could be switched off and electrically insulated duringand shortly after defibrillation/cardioversion shock delivery. Thecanister sense electrodes may also be placed on the electricallyinactive surface of the canister. In the embodiment of FIG. 2, there areactually four sensing electrodes, two on the subcutaneous lead and twoon the canister. In the preferred embodiment, the ability to changewhich electrodes are used for sensing would be a programmable feature ofthe S-ICD to adapt to changes in the patient physiology and size (in thecase of children) over time. The programming could be done via the useof physical switches on the canister, or as presently preferred, via theuse of a programming wand or via a wireless connection to program thecircuitry within the canister.

[0115] The canister could be employed as either a cathode or an anode ofthe S-ICD cardioversion/defibrillation system. If the canister is thecathode, then the subcutaneous coil electrode would be the anode.Likewise, if the canister is the anode, then the subcutaneous electrodewould be the cathode.

[0116] The active canister housing will provide energy and voltageintermediate to that available with ICDs and most AEDs. The typicalmaximum voltage necessary for ICDs using most biphasic waveforms isapproximately 750 Volts with an associated maximum energy ofapproximately 40 Joules. The typical maximum voltage necessary for AEDsis approximately 2000-5000 Volts with an associated maximum energy ofapproximately 200-360 Joules depending upon the model and waveform used.The S-ICD of the present invention uses maximum voltages in the range ofabout 700 to about 3150 Volts and is associated with energies of about40 to about 210 Joules. The capacitance of the S-ICD could range fromabout 50 to about 200 micro farads.

[0117] The sense circuitry contained within the canister is highlysensitive and specific for the presence or absence of life threateningventricular arrhythmias. Features of the detection algorithm areprogrammable and the algorithm is focused on the detection of V-FIB andhigh rate V-TACH (>240 bpm). Although the S-ICD of the present inventionmay rarely be used for an actual life threatening event, the simplicityof design and implementation allows it to be employed in largepopulations of patients at modest risk with modest cost by non-cardiacelectrophysiologists. Consequently, the S-ICD of the present inventionfocuses mostly on the detection and therapy of the most malignant rhythmdisorders. As part of the detection algorithm's applicability tochildren, the upper rate range is programmable upward for use inchildren, known to have rapid supraventricular tachycardias and morerapid ventricular fibrillation. Energy levels also are programmabledownward in order to allow treatment of neonates and infants.

[0118] Turning now to FIG. 4, the optimal subcutaneous placement of theS-ICD of the present invention is illustrated. As would be evidence to aperson skilled in the art, the actual location of the S-ICD is in asubcutaneous space that is developed during the implantation process.The heart is not exposed during this process and the heart isschematically illustrated in the figures only for help in understandingwhere the canister and coil electrode are three dimensionally located inthe left mid-clavicular line approximately at the level of theinframammary crease at approximately the 5th rib. The lead 21 of thesubcutaneous electrode traverses in a subcutaneous path around thethorax terminating with its distal electrode end at the posterioraxillary line ideally just lateral to the left scapula. This way thecanister and subcutaneous cardioversion/defibrillation electrode providea reasonably good pathway for current delivery to the majority of theventricular myocardium.

[0119]FIG. 5 illustrates a different placement of the present invention.The S-ICD canister with the active housing is located in the leftposterior axillary line approximately lateral to the tip of the inferiorportion of the scapula. This location is especially useful in children.The lead 21 of the subcutaneous electrode traverses in a subcutaneouspath around the thorax terminating with its distal electrode end at theanterior precordial region, ideally in the inframammary crease. FIG. 6illustrates the embodiment of FIG. 1 subcutaneously implanted in thethorax with the proximal sense electrodes 23 and 25 located atapproximately the left axillary line with thecardioversion/defibrillation electrode just lateral to the tip of theinferior portion of the scapula.

[0120]FIG. 7 schematically illustrates the method for implanting theS-ICD of the present invention. An incision 31 is made in the leftanterior axillary line approximately at the level of the cardiac apex.This incision location is distinct from that chosen for S-ICD placementand is selected specifically to allow both canister location moremedially in the left inframammary crease and lead positioning moreposteriorly via the introducer set (described below) around to the leftposterior axillary line lateral to the left scapula. That said, theincision can be anywhere on the thorax deemed reasonably by theimplanting physician although in the preferred embodiment, the S-ICD ofthe present invention will be applied in this region. A subcutaneouspathway 33 is then created medially to the inframmary crease for thecanister and posteriorly to the left posterior axillary line lateral tothe left scapula for the lead.

[0121] The S-ICD canister 11 is then placed subcutaneously at thelocation of the incision or medially at the subcutaneous region at theleft inframmary crease. The subcutaneous electrode 13 is placed with aspecially designed curved introducer set 40 (see FIG. 8). The introducerset comprises a curved trocar 42 and a stiff curved peel away sheath 44.The peel away sheath is curved to allow for placement around the ribcage of the patient in the subcutaneous space created by the trocar. Thesheath has to be stiff enough to allow for the placement of theelectrodes without the sheath collapsing or bending. Preferably thesheath is made out of a biocompatible plastic material and is perforatedalong its axial length to allow for it to split apart into two sections.The trocar has a proximal handle 41 and a curved shaft 43. The distalend 45 of the trocar is tapered to allow for dissection of asubcutaneous path 33 in the patient. Preferably, the trocar iscannulated having a central Lumen 46 and terminating in an opening 48 atthe distal end. Local anesthetic such as lidocaine can be delivered, ifnecessary, through the lumen or through a curved and elongated needledesigned to anesthetize the path to be used for trocar insertion shouldgeneral anesthesia not be employed. The curved peel away sheath 44 has aproximal pull tab 49 for breaking the sheath into two halves along itsaxial shaft 47. The sheath is placed over a guidewire inserted throughthe trocar after the subcutaneous path has been created. Thesubcutaneous pathway is then developed until it terminatessubcutaneously at a location that, if a straight line were drawn fromthe canister location to the path termination point the line wouldintersect a substantial portion of the left ventricular mass of thepatient. The guidewire is then removed leaving the peel away sheath. Thesubcutaneous lead system is then inserted through the sheath until it isin the proper location. Once the subcutaneous lead system is in theproper location, the sheath is split in half using the pull tab 49 andremoved. If more than one subcutaneous electrode is being used, a newcurved peel away sheath can be used for each subcutaneous electrode.

[0122] The S-ICD will have prophylactic use in adults where chronictransvenous/epicardial ICD lead systems pose excessive risk or havealready resulted in difficulty, such as sepsis or lead fractures. It isalso contemplated that a major use of the S-ICD system of the presentinvention will be for prophylactic use in children who are at risk forhaving fatal arrhythmias, where chronic transvenous lead systems posesignificant management problems. Additionally, with the use of standardtransvenous ICDs in children, problems develop during patient growth inthat the lead system does not accommodate the growth. FIG. 9 illustratesthe placement of the S-ICD subcutaneous lead system such that he problemthat growth presents to the lead system is overcome. The distal end ofthe subcutaneous electrode is placed in the same location as describedabove providing a good location for the coilcardioversion/defibrillation electrode 27 and the sensing electrodes 23and 25. The insulated lead 21, however is no longer placed in a taughtconfiguration. Instead, the lead is serpiginously placed with aspecially designed introducer trocar and sheath such that it hasnumerous waves or bends. As the child grows, the waves or bends willstraighten out lengthening the lead system while maintaining properelectrode placement. Although it is expected that fibrous scarringespecially around the defibrillation coil will help anchor it intoposition to maintain its posterior position during growth, a lead systemwith a distal tine or screw electrode anchoring system 52 can also beincorporated into the distal tip of the lead to facilitate leadstability (see FIG. 1). Other anchoring systems can also be used such ashooks, sutures, or the like.

[0123]FIGS. 10 and 11 illustrate another embodiment of the present S-ICDinvention. In this embodiment there are two subcutaneous electrodes 13and 13′ of opposite polarity to the canister. The additionalsubcutaneous electrode 13′ is essentially identical to the previouslydescribed electrode. In this embodiment the cardioversion/defibrillationenergy is delivered between the active surface of the canister and thetwo coil electrodes 27 and 27′. Additionally, provided in the canisteris means for selecting the optimum sensing arrangement between the foursense electrodes 23, 23′, 25, and 25′. The two electrodes aresubcutaneously placed on the same side of the heart. As illustrated inFIG. 6, one subcutaneous electrode 13 is placed inferiorly and the otherelectrode 13′ is placed superiorly. It is also contemplated with thisdual subcutaneous electrode system that the canister and onesubcutaneous electrode are the same polarity and the other subcutaneouselectrode is the opposite polarity.

[0124] Turning now to FIGS. 12 and 13, further embodiments areillustrated where the canister 11 of the S-ICD of the present inventionis shaped to be particularly useful in placing subcutaneously adjacentand parallel to a rib of a patient. The canister is long, thin, andcurved to conform to the shape of the patient's rib. In the embodimentillustrated in FIG. 12, the canister has a diameter ranging from about0.5 cm to about 2 cm without 1 cm being presently preferred.Alternatively, instead of having a circular cross sectional area, thecanister could have a rectangular or square cross sectional area asillustrated in FIG. 13 without falling outside of the scope of thepresent invention. The length of the canister can vary depending on thesize of the patient's thorax. Currently the canister is about 5 cm toabout 15 cm long with about 10 being presently preferred. The canisteris curved to conform to the curvature of the ribs of the thorax. Theradius of the curvature will vary depending on the size of the patient,with smaller radiuses for smaller patients and larger radiuses forlarger patients. The radius of the curvature can range from about 5 cmto about 35 cm depending on the size of the patient. Additionally, theradius of the curvature need not be uniform throughout the canister suchthat it can be shaped closer to the shape of the ribs. The canister hasan active surface, 15 that is located on the interior (concave) portionof the curvature and an inactive surface 16 that is located on theexterior (convex) portion of the curvature. The leads of theseembodiments, which are not illustrated except for the attachment port 19and the proximal end of the lead 21, can be any of the leads previouslydescribed above, with the lead illustrated in FIG. 1 being presentlypreferred.

[0125] The circuitry of this canister is similar to the circuitrydescribed above. Additionally, the canister can optionally have at leastone sense electrode located on either the active surface of the inactivesurface and the circuitry within the canister can be programmable asdescribed above to allow for the selection of the best sense electrodes.It is presently preferred that the canister have two sense electrodes 26and 28 located on the inactive surface of the canisters as illustrated,where the electrodes are spaced from about 1 to about 10 cm apart with aspacing of about 3 cm being presently preferred. However, the senseelectrodes can be located on the active surface as described above.

[0126] It is envisioned that the embodiment of FIG. 12 will besubcutaneously implanted adjacent and parallel to the left anterior 5thrib, either between the 4th and 5th ribs or between the 5th and 6thribs. However other locations can be used.

[0127] Another component of the S-ICD of the present invention is acutaneous test electrode system designed to simulate the subcutaneoushigh voltage shock electrode system as well as the QRS cardiac rhythmdetection system. This test electrode system is comprised of a cutaneouspatch electrode of similar surface area and impedance to that of theS-ICD canister itself together with a cutaneous strip electrodecomprising a defibrillation strip as well as two button electrodes forsensing of the QRS. Several cutaneous strip electrodes are available toallow for testing various bipole spacings to optimize signal detectioncomparable to the implantable system.

[0128] FIGS. 14 to 18 depict particular US-ICD embodiments of thepresent invention. The various sensing, shocking and pacing circuitry,described in detail above with respect to the S-ICD embodiments, mayadditionally be incorporated into the following US-ICD embodiments.Furthermore, particular aspects of any individual S-ICD embodimentdiscussed above, may be incorporated, in whole or in part, into theUS-ICD embodiments depicted in the following figures.

[0129] Turning now to FIG. 14, the US-ICD of the present invention isillustrated. The US-ICD consists of a curved housing 1211 with a firstand second end. The first end 1413 is thicker than the second end 1215.This thicker area houses a battery supply, capacitor and operationalcircuitry for the US-ICD. The circuitry will be able to monitor cardiacrhythms for tachycardia and fibrillation, and if detected, will initiatecharging the capacitor and then delivering cardioversion/defibrillationenergy through the two cardioversion/defibrillating electrodes 1417 and1219 located on the outer surface of the two ends of the housing. Thecircuitry can provide cardioversion/defibrillation energy in differenttypes of waveforms. In the preferred embodiment, a 100 uF biphasicwaveform is used of approximately 10-20 ms total duration and with theinitial phase containing approximately ⅔ of the energy, however, anytype of waveform can be utilized such as monophasic, biphasic,multiphasic or alternative waveforms as is known in the art.

[0130] The housing of the present invention can be made out of titaniumalloy or other presently preferred ICD designs. It is contemplated thatthe housing is also made out of biocompatible plastic materials thatelectronically insulate the electrodes from each other. However, it iscontemplated that a malleable canister that can conform to the curvatureof the patient's chest will be preferred. In this way the patient canhave a comfortable canister that conforms to the unique shape of thepatient's rib cage. Examples of conforming ICD housings are provided inU.S. Pat. No. 5,645,586, the entire disclosure of which is hereinincorporated by reference. In the preferred embodiment, the housing iscurved in the shape of a 5^(th) rib of a person. Because there are manydifferent sizes of people, the housing will come in differentincremental sizes to allow a good match between the size of the rib cageand the size of the US-ICD. The length of the US-ICD will range fromabout 15 to about 50 cm. Because of the primary preventative role of thetherapy and the need to reach energies over 40 Joules, a feature of thepreferred embodiment is that the charge time for the therapy,intentionally be relatively long to allow capacitor charging within thelimitations of device size.

[0131] The thick end of the housing is currently needed to allow for theplacement of the battery supply, operational circuitry, and capacitors.It is contemplated that the thick end will be about 0.5 cm to about 2 cmwide with about 1 cm being presently preferred. As microtechnologyadvances, the thickness of the housing will become smaller.

[0132] The two cardioversion/defibrillation electrodes on the housingare used for delivering the high voltage cardioversion/defibrillationenergy across the heart. In the preferred embodiment, thecardioversion/defibrillation electrodes are coil electrodes, however,other cardioversion/defibrillation electrodes could be used such ashaving electrically isolated active surfaces or platinum alloyelectrodes. The coil cardioversion/defibrillation electrodes are about5-10 cm in length. Located on the housing between the twocardioversion/defibrillation electrodes are two sense electrodes 1425and 1427. The sense electrodes are spaced far enough apart to be able tohave good QRS detection. This spacing can range from 1 to 10 cm with 4cm being presently preferred. The electrodes may or may not becircumferential with the preferred embodiment. Having the electrodes noncircumferential and positioned outward, toward the skin surface, is ameans to minimize muscle artifact and enhance QRS signal quality. Thesensing electrodes are electrically isolated from thecardioversion/defibrillation electrode via insulating areas 1423.Analogous types of cardioversion/defibrillation electrodes are currentlycommercially available in a transvenous configuration. For example, U.S.Pat. No. 5,534,022, the entire disclosure of which is hereinincorporated by reference, discloses a composite electrode with a coilcardioversion/defibrillation electrode and sense electrodes.Modifications to this arrangement is contemplated within the scope ofthe invention. One such modification is to have the sense electrodes atthe two ends of the housing and have the cardioversion/defibrillationelectrodes located in between the sense electrodes. Another modificationis to have three or more sense electrodes spaced throughout the housingand allow for the selection of the two best sensing electrodes. If threeor more sensing electrodes are used, then the ability to change whichelectrodes are used for sensing would be a programmable feature of theUS-ICD to adapt to changes in the patient physiology and size over time.The programming could be done via the use of physical switches on thecanister, or as presently preferred, via the use of a programming wandor via a wireless connection to program the circuitry within thecanister.

[0133] Turning now to FIG. 15, the optimal subcutaneous placement of theUS-ICD of the present invention is illustrated. As would be evident to aperson skilled in the art, the actual location of the US-ICD is in asubcutaneous space that is developed during the implantation process.The heart is not exposed during this process and the heart isschematically illustrated in the figures only for help in understandingwhere the device and its various electrodes are three dimensionallylocated in the thorax of the patient. The US-ICD is located between theleft mid-clavicular line approximately at the level of the inframammarycrease at approximately the 5^(th) rib and the posterior axillary line,ideally just lateral to the left scapula. This way the US-ICD provides areasonably good pathway for current delivery to the majority of theventricular myocardium.

[0134]FIG. 16 schematically illustrates the method for implanting theUS-ICD of the present invention. An incision 1631 is made in the leftanterior axillary line approximately at the level of the cardiac apex. Asubcutaneous pathway is then created that extends posteriorly to allowplacement of the US-ICD. The incision can be anywhere on the thoraxdeemed reasonable by the implanting physician although in the preferredembodiment, the US-ICD of the present invention will be applied in thisregion. The subcutaneous pathway is created medially to the inframammarycrease and extends posteriorly to the left posterior axillary line. Thepathway is developed with a specially designed curved introducer 1742(see FIG. 17). The trocar has a proximal handle 1641 and a curved shaft1643. The distal end 1745 of the trocar is tapered to allow fordissection of a subcutaneous path in the patient. Preferably, the trocaris cannulated having a central lumen 1746 and terminating in an opening1748 at the distal end. Local anesthetic such as lidocaine can bedelivered, if necessary, through the lumen or through a curved andelongated needle designed to anesthetize the path to be used for trocarinsertion should general anesthesia not be employed. Once thesubcutaneous pathway is developed, the US-ICD is implanted in thesubcutaneous space, the skin incision is closed using standardtechniques.

[0135] As described previously, the US-ICDs of the present inventionvary in length and curvature. The US-ICDs are provided in incrementalsizes for subcutaneous implantation in different sized patients. Turningnow to FIG. 18, a different embodiment is schematically illustrated inexploded view which provides different sized US-ICDs that are easier tomanufacture. The different sized US-ICDs will all have the same sizedand shaped thick end 1413. The thick end is hollow inside allowing forthe insertion of a core operational member 1853. The core membercomprises a housing 1857 which contains the battery supply, capacitorand operational circuitry for the US-ICD. The proximal end of the coremember has a plurality of electronic plug connectors. Plug connectors1861 and 1863 are electronically connected to the sense electrodes viapressure fit connectors (not illustrated) inside the thick end which arestandard in the art. Plug connectors 1865 and 1867 are alsoelectronically connected to the cardioverter/defibrillator electrodesvia pressure fit connectors inside the thick end. The distal end of thecore member comprises an end cap 1855, and a ribbed fitting 1859 whichcreates a water-tight seal when the core member is inserted into opening1851 of the thick end of the US-ICD.

[0136] The core member of the different sized and shaped US-ICD will allbe the same size and shape. That way, during an implantation procedures,multiple sized US-ICDs can be available for implantation, each onewithout a core member. Once the implantation procedure is beingperformed, then the correct sized US-ICD can be selected and the coremember can be inserted into the US-ICD and then programmed as describedabove. Another advantage of this configuration is when the batterywithin the core member needs replacing it can be done without removingthe entire US-ICD.

[0137]FIG. 14(a) illustrates an embodiment of the subcutaneous leadelectrode or “lead electrode assembly” 100. The lead electrode assembly100 is designed to provide an electrode 107 to be implantedsubcutaneously in the posterior thorax of a patient for delivery ofcardioversion/defibrillation energy. The lead electrode assembly 100 isfurther designed to provide a path for the cardioversion/defibrillationenergy to reach the electrode 107 from the operational circuitry withinthe canister 11 of an S-ICD such as the embodiment shown in FIG. 1.

[0138] The lead electrode assembly 100 comprises a connector 111, a lead21, a lead fastener 146, an electrode 107 and an appendage 118. Theconnector 111 is connected to the lead 21. The lead 21 is furtherconnected to the electrode 107 with the lead fastener 146. The appendage118 is mounted to the electrode 107.

[0139] The connector 111 provides an electrical connection between thelead 21 and the operational circuitry within the canister 11 of an S-ICDsuch as the embodiment shown in FIG. 1. Connector 111 is designed tomate with the connection port 19 on the canister 11. In the embodimentunder discussion, the connector 111 meets the IS-1 standard.

[0140] The lead 21 of the lead electrode assembly 100 provides anelectrical connection between the connector 111 and the electrode 107.The lead 21 comprises a distal end 101 and a proximal end 102. Thedistal end 101 of the lead 21 is attached to the connector 111. Theproximal end 102 of the lead 21 is attached to electrode 107 with thelead fastener 146.

[0141] The lead 21 has a lead length, l_(Lead), measured from theconnector 111 along the lead 21 to the lead fastener 146 of theelectrode 107. The length of the lead 21 is approximately 25 cm. Inalternative embodiments, the lead lengths range between approximately 5cm and approximately 52 cm.

[0142] The lead fastener 146 provides a robust physical and electricalconnection between the lead 21 and the electrode 107. The lead fastener146 joins the proximal end 102 of the lead 21 to electrode 107.

[0143] The electrode 107 comprises an electrically conductive memberdesigned to make contact with the tissue of the patient and transfercardioversion/defibrillation energy to the tissue of the patient fromthe S-ICD canister 11.

[0144] The electrode 107 illustrated is generally flat and planar,comprising a top surface 110, a bottom surface 115, a distal end 103 anda proximal end 104. The lead fastener 146 is attached to the top surface110 of the distal end 103 of the electrode 107.

[0145] The electrode 107 may have shapes other than planar. In analternate embodiment, the electrode 107 is shaped like a coil.

[0146] The appendage 118 is a member attached to the electrode 107 thatcan be gripped and used to precisely locate the lead electrode assembly100 during its surgical implantation within the patient.

[0147] The appendage 118 has a first end 105, a second end 106, a distaledge 121 and a proximal edge 129. The second end 106 of the appendage118 is attached to the top surface 110 of the electrode 107. Theappendage 118 is positioned such that its proximal edge 129 is withinapproximately 20 mm of the proximal end 104 of the electrode 107. Inalternate embodiments, the appendage 118 is attached to the electrode107 in other positions.

[0148] It is useful at this point, to set out several generaldefinitions for future reference in discussing the dimensions andplacement of appendages 118.

[0149] The appendage height, h_(Appendage), is defined as the distancefrom the point of the appendage 118 most distant from the electrode 107to a point of the appendage 118 closest to the electrode 107 measuredalong a line perpendicular to the top surface 110 of the electrode 107.The appendage height of the appendage 118 illustrated, for example,would be measured between the first end 105 of the appendage 118 and thesecond end 106 of the appendage 118.

[0150] The appendage height of the appendage 118 illustrated isapproximately 5 mm. In alternative embodiments, the appendage heightsrange between approximately 1 mm and approximately 10 mm.

[0151] The appendage interface is defined as the part of the appendage118 that joins it to the electrode 107. The appendage interface of theappendage 118 illustrated, for example, would be the second end 106 ofthe appendage 118.

[0152] The appendage length, l_(Appendage), is the length of theappendage 118 along the appendage interface. The appendage interface ofthe appendage 118 illustrated, for example, would be the length of thesecond end 106 of the appendage 118.

[0153] The appendage length of the appendage 118 illustrated in FIG. 14is approximately 1 cm. In alternative embodiments, appendage lengthsrange between approximately 2 mm and approximately 6 cm. In an alternateembodiment, the appendage 118 is substantially as long as the electrode107.

[0154] More particularly, the appendage 118 of the embodimentillustrated is a fin 120 comprising a fin core 122 (phantom view) and acoating 125.

[0155] The fin core 122 generally provides support for the fin 120. Thefin core 122 has a first end 126 and a second end 127. The second end127 of the fin core 122 is attached to the top surface 110 of theelectrode 107.

[0156] The fin core 122 comprises a metal selected from the groupconsisting essentially of titanium, nickel alloys, stainless steelalloys, platinum, platinum iridium, and mixtures thereof. In otherembodiments, the fin core 122 comprises any rugged material that can beattached to the first surface 110 of the electrode 107.

[0157] The coating 125 is disposed around the fin core 122. The coating125 provides a surface for the fin 120 that can be easily gripped duringthe implantation of the lead electrode assembly 100. The coating 125covering the fin core 122 is composed of molded silicone. In analternative embodiment, the coating 125 may be any polymeric material.In this specification, the term polymeric material includes the group ofmaterials consisting of a polyurethane, a polyamide, apolyeteretherketone (PEEK), a polyether block amide (PEBA), apolytetrafluoroethylene (PTFE), a silicone and mixtures thereof.

[0158] In one embodiment, the fin 120 is reinforced with a layer ofDacron® polymer mesh attached to the inside of the coating 125. Dacron®is a registered trademark of E.I. du Pont de Nemours and CompanyCorporation, Wilmington, Del. In another embodiment, the Dacron® polymermesh attached to the outside of the coating 125. In another embodiment,the fin 120 is reinforced with a layer of any polymeric material.

[0159]FIG. 14(b) illustrates a top view of the lead electrode assembly100. The electrode 107 is substantially rectangular in shape, comprisinga first pair of sides 108, a second pair of sides 109 and four corners112. In an alternative embodiment the electrode 107 has a shape otherthan rectangular. In this embodiment, the corners 112 of the electrode107 are rounded. In an alternative embodiment the corners 112 of theelectrode 107 are not rounded.

[0160] The first pair of sides 108 of the electrode 107 aresubstantially linear, substantially parallel to each other and areapproximately 1 cm in length. The second pair of sides 109 of theelectrode 107 are also substantially linear, substantially parallel witheach other and are approximately 5 cm in length. The bottom surface 115of the electrode 107 has an area of approximately 500 square mm. Inalternative embodiments, the first pair of sides 108 and the second pairof sides 109 of the electrode 107 are neither linear nor parallel.

[0161] In alternative embodiments, the length of the first pair of sides108 and second pair of sides 109 of the electrode 107 rangeindependently between approximately 1 cm and approximately 5 cm. Thesurface area of the bottom surface 115 of the electrode 107 rangesbetween approximately 100 sq. mm and approximately 2000 sq. mm. In oneembodiment, the first pair of sides 108 and second pair of sides 109 ofthe electrode 107 are linear and of equal length, such that theelectrode 107 is substantially square-shaped.

[0162] The electrode 107 comprises a sheet of metallic mesh 114 furthercomprised of woven wires 119. The metallic mesh 114 comprises a metalselected from the group consisting essentially of titanium, nickelalloys, stainless steel alloys, platinum, platinum iridium, and mixturesthereof. In other embodiments, the metallic mesh 114 comprises anyconductive material.

[0163] In an alternate embodiment, the electrode 107 comprises a solidmetallic plate. The metallic plate comprises a metal selected from thegroup consisting essentially of titanium, nickel alloys, stainless steelalloys, platinum, platinum iridium, and mixtures thereof. In otherembodiments, the solid plate comprises any conductive material.

[0164] The metallic mesh 114 is approximately a 150 mesh, havingapproximately 150 individual wires 119 per inch. In alternativeembodiments, the metallic mesh 114 ranges between approximately a 50mesh and approximately a 200 mesh. In this embodiment, the diameter ofthe wires 119 of the mesh is approximately 1 mil. In alternativeembodiments, the diameter of the wires 119 ranges between approximately1 and approximately 5 mils.

[0165] The metallic mesh 114 is first prepared by spot welding togetherthe wires 119 located along the first pair of sides 108 and second pairof sides 109 of the metallic mesh 114. The excess lengths of wires arethen ground or machined flush, so as to produce a smooth edge and toform a smooth border 113. In an alternate embodiment, the wires 119located along the first pair of sides 108 and second pair of sides 109of the metallic mesh 114 are bent in toward the metallic mesh 114 toform a smooth border 113.

[0166] The fin 120 is attached to the top surface 110 of the electrode107 in a position centered between the first pair of sides 108 of theelectrode 107. In other embodiments, the fin 120 is not centered betweenthe first pair of sides 108 of the electrode 107.

[0167] The fin 120 is planar shape comprising a first face 191 and asecond face 192. The first face 191 and the second face 192 of the fin120 are substantially parallel to the first pair of sides 108 of theelectrode 107. In other embodiments, the first face 191 and the secondface 192 of the fin 120 are positioned in orientations other thanparallel to the first pair of sides 108 of the electrode 107.

[0168] The first face 191 and the second face 192 of the fin 120 extendfrom and substantially perpendicular to the top surface 110 of theelectrode 107. In an alternative embodiment, the first face 191 and thesecond face 192 of the fin 120 extend from the top surface 110 of theelectrode 107 at other than right angles.

[0169] The fin core 122 of the fin 120 is spot welded to the metallicmesh 114 comprising the electrode 107. In another embodiment, the fin120 may be composed entirely of a polymeric material and attached to theelectrode 107 by means known in the art.

[0170]FIG. 14(c) illustrates in detail a section of the lead 21 of thisembodiment. The lead 21 comprises an electrically insulating sheath 141and an electrical conductor 142.

[0171] The electrically insulating sheath 141 is disposed around theelectrical conductor 142 (phantom view). The electrically insulatingsheath 141 prevents the cardioversion/defibrillation energy passingthrough the electrical conductor 142 to the electrode from passing intoobjects surrounding the lead 21. The electrically insulating sheath 141,comprises a tube 149 disposed around the electrical conductor 142. Thetube is composed of either silicone, polyurethane or compositematerials. One skilled in the art will recognize that the tube 149 couldalternately be composed of any insulating, flexible, bio-compatiblematerial suitable to this purpose.

[0172] In this embodiment, the electrical conductor 142 comprises threehighly-flexible, highly-conductive coiled fibers known as filars 147(phantom view). These fibers are wound in a helical shape through theelectrically insulating sheath 141. In an alternate embodiment, thefilars lie as linear cables within the electrically insulating sheath141. In another alternate embodiment, a combination of helically coiledand linear filars lie within the electrically insulating sheath 141.

[0173]FIG. 14(d) illustrates a cross-section of a filar 147. The filars147 of the embodiment illustrated comprise a metal core 144, a metaltube 143 and an insulating coating 140. The metal tube 143 is disposedaround the metal core 144. The insulating coating 140 is disposed aroundthe metal tube. The metal core 144 is made of silver and the metal tube143 is made of MP35N® stainless steel, a product of SPS Technologies ofJenkintown, Pa. The insulating coating 140 is made of teflon. The filars147 of this structure are available as DFT™ (drawn filled tube)conductor coil, available from Fort Wayne Metals Research Products Corp.of Fort Wayne, Ind.

[0174] In an alternative embodiment, the filars 147 further comprise anintermediate coating (not shown) disposed between the metal tube 143 andthe insulating coating 140. This intermediate coating is made ofplatinum, iridium ruthenum, palladium or an alloy of these metals.

[0175] In another alternative embodiment, the filars 147 comprise DBS™(drawn braised strands) also available from Fort Wayne Metals ResearchProducts Corp. of Fort Wayne, Ind.

[0176] Turning now to FIG. 14(e), a cross section of the lead fastener146 is shown in detail. The lead fastener 146 provides a robust physicaland electrical connection between the lead 21 and the electrode 107.

[0177] In this embodiment, the lead fastener 146 comprises a metal strip157, a crimping tube 154 and a crimping pin 156. The metal strip 157 hasa first end 150, a second end 151, and a middle portion 152. The firstend 150 and second end 151 of the metal strip 157 are separated by themiddle portion 152. The first end 150 and second end 151 of the metalstrip 157 are attached to the electrode 107. In this embodiment, thefirst end 150 and second end 151 of the lead fastener 146 are spotwelded to the top surface 110 of the metallic mesh 114 comprising theelectrode 107. In other embodiments, other fastening methods known inthe art can be used.

[0178] The middle portion 152 of the metal strip 157 is raised away fromthe electrode 107 to permit the crimping tube 154 and electricallyinsulating sheath 141 of the lead 21 to fit between the metal strip 157and the electrode 107.

[0179] The middle portion 152 of the metal strip 157 contains a crimppoint 148. The crimp point 148 squeezes the crimping tube 154 andelectrically insulating sheath 141 of the lead 21 threby gripping it,and thereby providing a robust structural connection between the lead 21and the electrode 107.

[0180] The filars 147 of the lead 21 are situated between the crimpingtube 154 and crimping pin 156. The crimping tube 154 has a crimpingpoint 155 which causes the filars 147 to be squeezed between crimpingtube 154 and crimping pin 156. A gap 159 in the electrically insulatingsheath 141 allows the crimping tube 155 to make contact the electrode107, thereby forming a robust electrical connection.

[0181] The metal strip 157, the crimping tube 154 and crimping pin 156are each made of platinum iridium. In an alternative embodiment, themetal strip 157, crimping tube 154 and crimping pin 156 are each made ofa metal selected from the group consisting essentially of titanium,nickel alloys, stainless steel alloys, platinum, platinum iridium, andmixtures thereof. In alternative embodiment, the metal strip 157,crimping tube 154 and crimping pin 156 are each made of any conductivematerial.

[0182]FIG. 14(f) illustrates an exploded view of the lead fastener 146.In other embodiments, other types of lead fasteners 146 known in the artare used.

[0183]FIG. 15(a) illustrates an alternative embodiment of the leadelectrode assembly 100. This embodiment is substantially similar to thelead electrode assembly 100 illustrated in FIGS. 14(a)-14(f). In thisembodiment, however, the appendage 118 lacks a fin core 122. Moreover,as seen in FIG. 15(a) the lead electrode assembly 100 of this embodimentfurther comprises a backing layer 130 and stitching 139. The backinglayer 130 acts to insulate the electrode 107 so thatcardioversion/defibrillation energy may not pass to the tissue of thepatient that surrounds the top surface 110 of the electrode 107. Thishas the effect of focusing the cardioversion/defibrillation energytoward the heart of the patient through the bottom surface 115 of theelectrode 107.

[0184] The backing layer 130 comprises a base portion 158 and anintegrated fin 120. The base portion 158 of the backing layer 130comprises a first surface 131, a second surface 132, a first side 133and a second side 134.

[0185] The base portion 158 of the backing layer 130 is attached to theelectrode 107 such that the second surface 132 of the backing layer 130lies directly adjacent to the top surface 110 of the electrode 107.

[0186] The base portion 158 of the backing layer 130 is formed so thatthe first side 133 and the second side 134 are substantially paralleland of substantially the same size as the first pair of sides 108 of theelectrode 107.

[0187]FIG. 15(b) illustrates a top view of the lead electrode assembly100 of this embodiment. The base portion 158 of the backing layer 130further comprises a distal end 137 and a proximal end 138.

[0188] The distal end 137 and proximal end 138 of the backing layer 130are parallel to and of substantially the same size as the second pair ofsides 109 (hidden) of the electrode 107. The backing layer 130 containsa notch 136 on its distal end 137, through which the lead fastener 146rises.

[0189] The base portion 158 of the backing layer 130 is attached to theelectrode 107 with stitching 139. The stitching is composed of nylon. Inalternate embodiments, the stitching is composed of any polymericmaterial.

[0190] The backing layer 130 is composed of polyurethane. In analternative embodiment, the backing layer is composed of moldedsilicone, nylon, or Dacron®. In alternative embodiments, the backinglayer is composed of any polymeric material.

[0191] The integrated fin 120 of the backing layer 130 is formed fromthe same piece of material as the backing layer 130. The integrated fin120 has the same shape and dimensions as the fin 120 of the embodimentin FIG. 14.

[0192] In one embodiment, the integrated fin 120 is reinforced with alayer of Dacron® polymer mesh attached to the integrated fin 120. Inanother embodiment, the integrated fin 120 is reinforced with a layer ofany polymeric material.

[0193]FIG. 16(a) illustrates an alternative embodiment of the leadelectrode assembly 100. This embodiment is substantially similar to thelead electrode assembly 100 illustrated in FIGS. 14(a)-14(e). In thisembodiment, however, the fin 120 has a different construction.

[0194] Here, fin 120 comprises a first fin section 165, a second finsection 160 and stitching 168. The first fin section 165 is arectangular sheet of polymeric material comprising an inside face 167,an outside face 166, a first side 175 and a second side 174. The firstside 175 and second side 174 of the first fin section 165 aresubstantially parallel and of substantially the same size.

[0195] A line 173 divides the first fin section 165 into a first half171 and a second half 172. The line 173 runs parallel to the first side175 of the first fin section 165. The first half 171 of the first finsection 165 lies on one side of line 173. The second half 172 of thefirst fin section 165 lies on the other side of the line 173.

[0196] The second fin section 160 is a rectangular sheet of polymericmaterial of the same size as the first fin section 165 comprising aninside face 162 and an outside face 161. The second fin section 160 isdivided in half substantially similarly to the first fin section 165,thereby forming a first half 163 and a second half 164 of the second finsection 160.

[0197] In an alternate embodiment, the first fin section 165 and secondfin section are not rectangular in shape. In an alternate embodiment,the first fin section 165 and second fin section have an oval shape.

[0198] The first half 171 of the first fin section 165 is fastened tothe first half 163 of the second fin section 160. The inside face 167 ofthe first half 171 of the first fin section 165 faces the inside face162 of the first half 163 of the second fin section 160. The first finsection 165 is fastened the second fin section 160 with stitching 168.

[0199] The fin 120 is attached to the top surface 110 of the electrode107. To accomplish this, the second half 172 of the first fin section165 is attached to the top surface 110 of the electrode 107 with thestitching 169. The second half 164 of the second fin section 160 issimilarly attached to the top surface 110 of the electrode 107 withstitching (not shown).

[0200] In one embodiment, the fin 120 is reinforced with a layer ofDacron® polymer mesh positioned between the first fin section 165 andthe second fin section 160 of the integrated fin 120. In anotherembodiment, the Dacron® polymer mesh is attached only to the first finsection 165 or the second fin section 160. In other embodiments, theintegrated fin 120 is reinforced with a layer of any polymeric materialattached to either or both fin sections.

[0201] The appendage height of the fin 120 in this embodiment isapproximately 5 mm. In alternative embodiments, the appendage heightsrange between approximately 1 mm and approximately 10 mm. The appendagelength of the fin 120 in this embodiment is approximately 1 cm. Inalternative embodiments, appendage lengths range between approximately 2mm and approximately 6 cm. In one embodiment, the appendage length ofthe fin 120 is such that the fin 120 is substantially as long as theelectrode 107.

[0202]FIG. 17(a) illustrates a side plan view of an alternativeembodiment of the lead electrode assembly 100. The lead electrodeassembly 100 comprises a connector 111, a lead 21, a lead fastener 146,an electrode 107, a backing layer 130 with an integrated fin tab 180, amolded cover 220 and an appendage 118.

[0203] The connector 111 is connected to the lead 21. The lead 21 isfurther connected to the electrode 107 with the lead fastener 146. Thebacking layer 130 is positioned over the electrode 107. The fin tab 180protrudes from the backing layer 130. The molded cover 220 is disposedaround the lead fastener 146 and the backing layer 130. The molded cover220 is further disposed around the fin tab 180 of the backing layer 118to form the appendage 118. The molded cover 220 also partially envelopsthe electrode 107.

[0204] The connector 111 and the lead 21 are substantially similar tothe connector 111 and the lead 21 described with reference to FIGS.14(a)-14(f). The lead comprises a distal end 101 and a proximal end 102.The distal end 101 of the lead 21 is attached to the connector 111. Theproximal end 102 of the lead 21 is connected to the electrode 107 by thelead fastener 146.

[0205] In this embodiment, the lead fastener 146 comprises a firstcrimping tube 200, a crimping pin 202 and a second crimping tube 201.The first crimping tube 200 connects the proximal end 102 of the lead 21to the crimping pin 202. The second crimping tube 201 connects thecrimping pin 202 to the electrode 107.

[0206] The electrode 107 comprises a distal end 103 (phantom view), aproximal end 104, a top surface 110 and a bottom surface 115. Theelectrode further comprises three sections: a main body 217, a mandrel219 and a mandrel neck 218.

[0207] The main body 217 of the electrode 107 is the region of theelectrode 107 that makes contact with the tissue of the patient andtransfers the cardioversion/defibrillation energy to the patient. Thisregion is substantially rectangular, comprising a first pair of sides108 (not shown) and a second pair of sides 109. The first pair of sides108 of the electrode 107 are substantially parallel to each other. Thesecond pair of sides 109 of the electrode 107 are also substantiallyparallel to each other. In another embodiment, the first pair of sides108 and the second pair of sides 109 of the electrode 107 arenonparallel. The main body 217 of the electrode 107 is positioned underthe backing layer 130, so that the top surface 110 of the electrodefaces the backing layer 130.

[0208] The mandrel 219 is a region of the electrode 107 shaped tofacilitate the connection of the electrode 107 to the lead 21 via thelead fastener 146. The mandrel of the electrode is crimped onto to thecrimping pin 202 of the lead fastener 146 with the second crimping tube201, so that a robust physical and electrical connection is formed. Themain body 217 of the electrode 107 is connected to the mandrel 219 ofthe electrode 107 via the mandrel neck 218 of the electrode 107.

[0209] The backing layer 130 comprises a base portion 158 and anintegrated fin tab 180. The base portion 158 of the backing layer 130comprises a first surface 131, a second surface 132, a distal end 137and a proximal end 138.

[0210] The base portion 158 of the backing layer 130 is positioned suchthat its second surface 132 is adjacent to the top surface 110 of theelectrode 107. The base portion 158 of the backing layer 130 is sizedand positioned so that the distal end 137 and proximal end 138 of thebase portion 158 of the backing layer 130 overlay the second pair ofsides 109 of the main body 217 of the electrode 107. The distal end 137and proximal end 138 of the are also substantially parallel and ofsubstantially the same size as the second pair of sides 109 of theelectrode 107.

[0211] The integrated fin tab 180 of the backing layer 130 is formedfrom the same piece of material as the base portion 158 of the backinglayer 130. The integrated fin tab 180 is formed on the first surface 131of the base portion 158 of the backing layer 130.

[0212] The integrated fin tab 180 comprises a proximal edge 183, adistal edge 184, a top 185 and a bottom 186. The bottom 186 of theintegrated fin tab 180 is joined to the first surface 131 of the baseportion 158 of the backing layer 130. The proximal edge 183 and thedistal edge 184 of the integrated fin tab 180 extend from, andsubstantially perpendicular to the first surface 131 of the base portion158 of the backing layer 130. The proximal edge 183 and distal edge 184of the integrated fin tab 180 are parallel with each other. Theintegrated fin tab 180 is positioned so that its proximal edge 183 issubstantially flush with the proximal end 138 of the base portion 158 ofthe backing layer 130.

[0213] The backing layer 130 is composed of polyurethane. In analternative embodiment, the backing layer 130 is composed of silicone.In another alternative embodiment, the backing layer 130 is composed ofany polymeric material.

[0214] The molded cover 220 envelops and holds together the componentsof the lead electrode assembly 100. The molded cover 220 also providesrigidity to the lead electrode assembly 100. The molded cover 220envelops the lead fastener 146 and the backing layer 130. The fin 120 isformed when the molded cover 220 covers the fin tab 180. The thicknessof the resulting fin 120 is approximately 2 mm. In alternateembodiments, the thickness of the fin 120 is between approximately 1 mmand approximately 3 mm.

[0215] The appendage height of the fin 120 in this embodiment isapproximately 5 mm. In alternative embodiments, the appendage heightsrange between approximately 1 mm and approximately 10 mm. The appendagelength of the fin 120 in this embodiment is approximately 1 cm. Inalternative embodiments, appendage lengths range between approximately 2mm and approximately 6 cm. In one embodiment, the appendage length ofthe fin 120 is such that the fin is as long as the backing layer. In oneembodiment, the appendage length of the fin 120 is such that the fin isas long as the electrode 107. In one embodiment, the appendage length ofthe fin 120 is such that the fin is as long as the molded cover 220.

[0216] The molded cover 220 also partially covers the bottom surface 115of the electrode 107. In this way, the molded cover 220 attaches thebacking layer 130 to the electrode 107.

[0217] The molded cover 220 in this embodiment is made of silicone. Inan alternate embodiment, the molded cover 220 is made of any polymericmaterial. Stitching 360 holds the molded cover 220, the electrode 107and the backing layer 130 together.

[0218] In one embodiment, the fin 120 is reinforced with a layer ofDacron® polymer mesh positioned between the molded cover 220 and theintegrated fin tab 180. In another embodiment, the Dacron® polymer meshis attached only to the molded cover 220. In other embodiments, the fin120 is similarly reinforced with a layer of any polymeric material.

[0219] As shown in FIG. 17(b), the fin 120 of the embodiment illustratedin FIG. 17(a) can alternately have a sloped shape. The sloped shape canreduce the resistance offered by the tissue of the patient as it slidesagainst the fin 120 during the insertion of the lead electrode assembly100 into the patient. The slope-shaped fin 120 is constructed so thatthe proximal edge 183 and distal edge 184 of the integrated fin tab 180are not parallel with each other. Instead, proximal edge 183 of theintegrated fin tab 180 can be curved so that the proximal edge 183 ofthe integrated fin tab 180 is closer to the proximal edge 184 at the top185 of the integrated fin tab 180, than at the bottom 186 of theintegrated fin tab 180. In alternate embodiments, the proximal edge 183of the integrated fin tab 180 is not curved. Instead, the proximal edge183 of the integrated fin tab 180 is straight, and forms an acute anglewith the first surface 131 of the backing layer 130. In one alternateembodiment, the proximal edge 183 of the integrated fin tab 180 forms a45 degree angle with the first surface 131 of the backing layer 130. Inalternate embodiments, the distal edge 184 of the integrated fin tab 180is curved. In alternate embodiments, the distal edge 184 of theintegrated fin tab 180 is straight and shaped so that it forms an acuteangle with the first surface 131 of the backing layer 130.

[0220]FIG. 17(c) illustrates a front plan view of the lead electrodeassembly 100 seen in FIG. 17(a). The base portion 158 of the backinglayer 130 further comprises a first side 133 and second side 134. Thefirst side 133 and second side 134 of the base portion 158 of thebacking layer 130 are substantially parallel. In an alternateembodiment, the first side 133 and second side 134 of the backing layer130 are not parallel. The base portion 158 of the backing layer 130 issized so that it is substantially the same size and shape as the mainbody 217 of the electrode 107.

[0221] The integrated fin tab 180 of the backing layer 130 is planar,comprising a first face 181 and a second face 182. The first face 181and second face 182 of the fin tab 180 are substantially parallel witheach other and with the first side 133 and second side 134 of thebacking layer 130. The first face 181 and second face 182 of the fin tab180 extend from, and substantially perpendicular to the first surface131 of the backing layer 130. In another embodiment, the first face 181and second face 182 of the fin tab 180 extend from the first surface 131of the backing layer 130 at angles other than a right angle.

[0222] In an alternate embodiment, the first face 181 and a second face182 of the integrated fin tab 180 of the backing layer 130 are notsubstantially parallel to each other. Instead, they are angled, suchthat they are closer together at the top 185 than they are at the bottom186 of the integrated fin tab 180. This shape can reduce the resistanceoffered by the tissue of the patient as it slides against the fin 120during the insertion of the lead electrode assembly 100 into thepatient.

[0223] In another embodiment, the first face 181 and a second face 182of the integrated fin tab 180 of the backing layer 130 are angled, suchthat they are further apart at the top 185 than they are at the bottom186 of the integrated fin tab 180. This shape can make the fin 120easier to grip with a tool, such as a hemostat.

[0224] The fin tab 180 extends from the backing layer 130 at a positioncentered between the first side 133 and the second side 134 of thebacking layer 130. In an alternate embodiment, the fin tab 180 is notcentered between the first side 133 and the second side 134 of thebacking layer 130.

[0225] An eyelet 301 is formed in the fin 120 of this embodiment. Theeyelet can be used to facilitate the capture of the lead electrodeassembly by a tool. The eyelet is formed as a hole 225 through themolded cover 220 and between the faces 181 and 182 of fin tab 180. In analternate embodiment, no eyelet is formed in the fin 120.

[0226] The bottom surface 115 of the electrode 107 comprises a periphery213 and a center 211. The molded cover 220 forms a skirt 222 around theperiphery 213 of the bottom surface 115 of the electrode 107. The skirt222 of the molded cover 220 covers the periphery 213 of the bottomsurface 115 of the electrode 107.

[0227] The skirt 222 of the molded cover 220 can act to focuscardioversion/defibrillation energy emitted from the electrode 107 ofthe lead electrode assembly 100 toward the heart of the patient. Becausethe thorax of a patient is surrounded by a layer of fat that is somewhatconductive, the cardioversion/defibrillation energy may tend to arcthrough this layer to reach the active surface 15 of the canister 11(seen in FIG. 1) without passing through the patient's heart. The skirt222 of the lead electrode assembly 100 acts to minimize the loss ofcardioversion/defibrillation energy to surrounding body tissues, or frombeing diverted away from the patient's heart.

[0228] The center 211 of the bottom surface 115 of the electrode 107 isnot covered by the molded cover 220 and is left exposed. The width ofthe periphery 213 of the bottom surface 115 of the electrode 107 coveredby the molded cover 220 is approximately 0.125 cm.

[0229] The area of the exposed center 211 of the bottom surface 115 ofthe electrode 107 is approximately 500 square mm. In alternativeembodiments, the length of the first pair of sides 108 and the secondpair of sides 109 of the electrode 107 vary, such that the area of thecenter 211 of the bottom surface 115 of the electrode has a surface areabetween approximately 100 sq. mm. and approximately 2000 sq. mm.

[0230]FIG. 17(d) illustrates an exploded top view of the lead fastener146 of the embodiments illustrated in FIGS. 17(a)-17(c). The leadfastener connects the proximal end 102 of the lead 21 and the distal end103 of the electrode 107.

[0231] In this embodiment, the lead fastener 146 comprises a firstcrimping tube 200, a crimping pin 202 and a second crimping tube 201.The crimping pin 202 comprises a first side 203 and a second side 204.

[0232] The crimping tube 200 crimps the filars 147 of the lead 21 (here,only one representative filar 147 is shown) to the first side 203 ofcrimping pin 202. The mandrel 219 of the electrode 107 is then wrappedaround the second side 204 of the crimping pin 202. Crimping tube 201crimps the mandrel 219 to the second side 204 of the crimping pin 202.

[0233] The first crimping tube 200, the second crimping tube 201 and thecrimping pin 202 are each made of platinum iridium. In an alternativeembodiment, the first crimping tube 200, the second crimping tube 201and the crimping pin 202 are each made of a metal selected from thegroup consisting essentially of titanium, nickel alloys, stainless steelalloys, platinum, platinum iridium, and mixtures thereof. In otherembodiments, the first crimping tube 200, the second crimping tube 201and the crimping pin 202 each comprise any conductive material.

[0234] The electrode 107 in this embodiment comprises a sheet ofmetallic mesh 206 prepared by the process described with reference toFIG. 14. The electrode 107 has a width measured parallel to the secondpair of sides 109 of the electrode 107. The width of the mandrel neck218 of the electrode 107 is approximately 3 mm wide. The width of themandrel of the electrode 107 is approximately 5 mm wide.

[0235] The first pair of sides 108 of the electrode 107 areapproximately 5 cm in length. The second pair of sides 109 of theelectrode 107 are approximately 1.9 cm in length. In alternativeembodiments, the length of the first pair of sides 108 and the secondpair of sides 109 of the electrode 107 range independently fromapproximately 1 cm to approximately 5 cm.

[0236] The electrode 107 of this embodiment further comprises fourcorners 112. The corners 112 of the electrode 107 are rounded. In analternate embodiment, the corners 112 of the electrode 107 are notrounded.

[0237] FIGS. 17(e)-17(g) illustrate the size and position of the fin 120on the molded cover of the lead electrode assembly 100.

[0238] FIGS. 18(a)-18(c) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiments illustrated in FIGS. 17(a)-17(g). In this embodiment,however, the appendage height of the fin 120 is approximately 1 cm. Theappendage length of the fin 120 in this embodiment is approximately 3.5cm.

[0239] As shown in FIG. 18(a), stitching 302 is placed through themolded cover 220 and the fin 120 to prevent the molded cover 220 fromsliding off the fin tab 180 when the molded cover 220 is subjected to aforce directed away from the electrode 107.

[0240] As shown in FIG. 18(c), the fin 120 (phantom view) extendsapproximately two thirds of the length of the electrode 107.

[0241]FIG. 19 illustrates an alternative embodiment of the leadelectrode assembly 100. This embodiment is substantially similar to theembodiments illustrated in FIGS. 17(a)-17(g). In this embodiment,however, the backing layer 130 (not shown) inside the molded cover 220is curved. This results in an electrode 107 that has a curvature ofradius r, such that the bottom surface 115 of the electrode 107 isconcave.

[0242] Because a curved electrode 107 may more closely approximate thecurvature of the patient's ribs, this curvature may have the effect ofmaking the lead electrode assembly 100 more comfortable for the patient.In one embodiment, the radius r of the curvature varies throughout theelectrode 107 such that it is intentionally shaped to approximate theshape of the ribs. Lead electrode assemblies 100 can be custommanufactured with an electrode 107 with a curvature r that matches thecurvature of the intended patient's ribcage in the vicinity of theribcage adjacent to which the electrode 107 is to be positioned.

[0243] In an alternative embodiment, lead electrode assemblies 100 aremanufactured with an electrode 107 with a radius r that matches thecurvature of the ribcage of a statistically significant number ofpeople.

[0244] In another embodiment, lead electrode assemblies 100 withelectrodes 107 of varying curvatures can be manufactured to allow anelectrode radius r to be selected for implantation based on the size ofthe patient. Smaller radii can be used for children and for smalleradult patients. Larger radii can be used for larger patients. The radiusr of the curvature can range from approximately 5 cm to approximately 35cm depending on the size of the patient.

[0245] In an alternative embodiment, the electrode 107 of the leadelectrode assembly 100 is flexible, such that it can be bent to conformto the curvature of the intended patient's rib cage at the time ofimplantation.

[0246] FIGS. 20(a)-20(c) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiments illustrated in FIGS. 17(a)-17(g). In this embodiment,however, the backing layer 130 lacks an integrated fin tab 180 mountedon the first surface 131 of the backing layer 130. Moreover, thisembodiment further comprises a backing layer 400 having a fin tab 405.

[0247] FIGS. 20(a) and 20(b) illustrate only the backing layer 400, thefin tab 405 and the electrode 107 of this embodiment as they arepositioned relative to each other in the complete embodiment. Othercomponents of the embodiment are not shown. FIG. 20(c) shows theembodiment in a complete form.

[0248]FIG. 20(a) illustrates a top plan view of the backing layer 400and the electrode 107. The backing layer 400 is positioned over theelectrode 107. The electrode 107 of this embodiment is substantiallysimilar to the electrode 107 of the embodiment illustrated in FIG.17(d). In the complete embodiment, the mandrel 219 of the electrode 107is joined to the lead 21 (not shown) by a lead fastener 146 (not shown)as shown in FIG. 17(a).

[0249] The backing layer 400 is a flat, planar member comprising adistal end 137 and a proximal end 138. The backing layer 400 furthercomprises a first side 133, a second side 134, a first surface 131, anda second surface 132 (not shown). The backing layer 400 furthercomprises a width, W, measured as the distance between the first side133 and the second side 134.

[0250] The backing layer 400 includes a fin tab 405 that is formed fromthe same piece of material as the backing layer 400. The first side 133of the backing layer 400 lies over one of the first pair of sides 108 ofthe electrode 107 except over a fin tab region 407. In the fin tabregion 407, the backing layer 400 is wider than the electrode 107. Inthe fin tab region 407, the first side 133 forms a fin tab 405 thatprotrudes from part of the first side 133 of the backing layer 400outside the fin tab region 407. The fin tab 405 extends from the firstside 133 of the backing layer 400 in an orientation substantiallyparallel to the top surface 110 of the electrode 107, beyond the firstside 108 (phantom view) of the electrode 107.

[0251] The fin tab 405 comprises a first face 410 and a second face 411(not shown). The first face 410 of the fin tab 405 is an extension ofthe first surface 131 of the backing layer 400. The second face 411 ofthe fin tab 405 is an extension of the second surface 132 of the backinglayer 400.

[0252] Aside from the fin tab 405, the backing layer 405 is formed sothat it is of substantially the same size and shape as the main body 217of the electrode 107.

[0253] The backing layer 400, including the fin tab 405, is composed ofpolyurethane. In an alternate embodiments the backing layer 400 and fintab 405 are composed of any polymeric material.

[0254]FIG. 20(b) is a side plan view of the backing layer 400 and theelectrode 107. The backing layer 400 is positioned over the electrode107 such that the second surface 132 of the backing layer 400 is placedadjacent to the top surface 110 of the electrode 107.

[0255]FIG. 20(c) illustrates a bottom plan view of the completeembodiment, in which the backing layer 400 (not shown), the leadfastener 146 (not shown) and the fin tab 405 (phantom view) are coatedwith a molded cover 220. When the molded cover 220 is applied over thebacking layer 400, a fin 424 is formed over the fin tab 405 (phantomview). The fin 424 comprises a proximal end 404 and a distal end 403.

[0256] In one embodiment, the fin 424 is reinforced with a layer ofDacron® polymer mesh positioned between the molded cover 220 and the fintab 405. In another embodiment, the Dacron® polymer mesh is attachedonly to the molded cover 220. In other embodiments, the fin 424 issimilarly reinforced with a layer of any polymeric material.

[0257] The appendage height, h_(Appendage), of the fin 424 of thisembodiment is approximately 5 mm. In alternative embodiments, theappendage heights range between approximately 1 mm and approximately 10mm. The appendage length, L_(Appendage), of the fin 424 of thisembodiment is measured between the proximal end 404 and the distal end403 of the fin 424. L_(Appendage) is measured where the fin 424 joinsthe rest of the lead electrode assembly 100. In this embodiment, theappendage length is approximately 1 cm. In alternative embodiments, theappendage lengths range between approximately 2 mm and approximately 6cm. In one embodiment, the appendage length of the fin 424 is such thatthe fin 424 runs the length of the electrode 107. In one embodiment, theappendage length of the fin 424 is such that the fin 424 runs the lengthof the backing layer 130 (not shown). In one embodiment, the appendagelength of the fin 424 is such that the fin 424 runs the length of themolded cover 220.

[0258]FIG. 20(d) illustrates a bottom plan view of an alternateembodiment of the lead electrode assembly 100. This embodiment issubstantially similar to the lead electrode assembly 100 illustrated inFIGS. 20(a)-20(c). In this embodiment, however, proximal end 404 of thefin 424 is sloped. The slope shape of the fin 424 is formed by the shapeof the fin tab 405 (phantom view) inside the fin 424. The backing layer400 gradually widens in the fin tab region 407 (not shown) with distancefrom the proximal end 138 (not shown) to the distal end 137 (not shown)of the backing layer 130 (not shown) until the appendage height isreached. The proximal end 404 of the fin 424 is straight and forms anacute angle with the first side 133 of the base portion 158 of thebacking layer 130 (not shown). In an alternate embodiment, the proximalend 404 of the fin 424 forms a 45 degree angle with the first side 133of the base portion 158 of the backing layer 130 (not shown). In anotherembodiment, the proximal end 404 of the fin 424 is curved slope.

[0259] In alternate embodiments, the distal end 403 of the fin 424 isstraight and shaped so that it forms an acute angle with the first side133 of the base portion 158 of the backing layer 130 (not shown). Inalternate embodiments, the distal end 403 of the fin 424 is curved.

[0260] FIGS. 21(a)-21(c) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiment illustrated in FIGS. 15(a)-15(b). The integrated fin 120is absent, however, from the backing layer 130.

[0261] The lead electrode assembly 100 of this embodiment furthercomprises a cylindrical rod 500 having a loop 515 formed therein. Theloop 515 comprises the appendage 118 of this embodiment. The loop 515 isa member attached to the electrode 107 that can be gripped and used toprecisely locate the electrode 107 during its surgical implantationwithin the patient.

[0262]FIG. 21(a) illustrates a side plan view of the embodiment. Thecylindrical rod 500 comprises a first straight portion 510, a secondstraight portion 512 and a portion formed into a loop 515. The firststraight portion 510 is separated from the second straight portion 512by the loop 515.

[0263] The rod 500 is made of platinum iridium. In an alternativeembodiment, the rod 500 is made of titanium or platinum.

[0264] The first straight portion 510 and second straight portion 512are spot welded to the top surface 110 of the electrode 107. The loop515 in the rod 500 extends away from the top surface 110 of theelectrode 107.

[0265] The backing layer 130 is similar to the backing layer 130illustrated in FIGS. 15(a)-15(b). The backing layer 130 is disposed overthe electrode 107. The first straight portion 510 and second straightportion 512 of the rod 500 are positioned between the second surface 132of the backing layer 130 and the top surface 110 of the electrode 107.

[0266]FIG. 21(b) illustrates a cross-sectional rear plan view of theembodiment of the lead electrode assembly shown in FIG. 21(a). The firststraight portion 510 and second straight portion 512 are positioned suchthat they are parallel to the first pair of sides 108 of the electrode107. The first straight portion 510 and second straight portion 512 areboth centered between the first pair of sides 108 of the electrode 107.In an alternative embodiment, the first straight portion 510 and secondstraight portion 512 are not parallel to and centered between the firstpair of sides 108 of the electrode 107.

[0267]FIG. 21(c) illustrates a top plan view of the embodiment of thelead electrode assembly shown in FIG. 21(a). An aperture 517 is formedin the backing layer 130. The aperture 517 in the backing layer ispositioned such that the loop 515 extends through and beyond theaperture 517 in a direction away from the top surface 110 of theelectrode 107. The backing layer 130 is attached to the electrode 107with stitching 139.

[0268] FIGS. 22(a)-22(d) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiment illustrated in FIGS. 15(a)-15(b). This embodimentcomprises a backing layer 610, however, that lacks the integrated fin120 illustrated in FIGS. 15(a)-15(b).

[0269]FIG. 22(a) illustrates a top plan view of the backing layer 610 ofthis embodiment prior to its attachment to the rest of the leadelectrode assembly 100. The backing layer 610 is cut in a pattern asshown. The backing layer comprises a first surface 131, a second surface132 (not shown), a distal end 137, a proximal end 138, a first side 133,a second side 134 and an indented fin-forming region 620. The indentedfin-forming region 620 comprises a first edge 690 and a second edge 691.

[0270] The backing layer 610 is formed so that the first side 133 andthe second side 134 are substantially parallel and of substantially thesame size as the first pair of sides 108 of the electrode 107. Theproximal end 138 is formed so that it is substantially perpendicular tothe first side 133 and the second side 134 of the backing layer 610. Theproximal end 138 is longer than the second pair of sides 109 of theelectrode 107 by a length A. The backing layer 610 has a varying width Cmeasured from its distal end 137 to its proximal end 138 along a lineparallel to its first side 133.

[0271] The backing layer is divided into three sections. A first backingsection 693, a second backing section 692 and an indented fin-formingregion 620 of length A. The length of the fin-forming region 620, A, isapproximately 10 mm. In other embodiments, the length of the fin-formingregion 620, A, ranges between approximately 2 mm and approximately 20mm.

[0272] The area within the indented fin-forming region 620 is equallydivided into a first fin area 612 and a second fin area 615. Thedividing line 617 between the first fin area 612 and the second fin area615 is substantially parallel to the first side 133.

[0273] The width, C, of the backing layer 610 is equal to the distancebetween the second pair of sides 109 of the electrode 107 except in theindented fin-forming region 620. In the indented fin-forming region 620,the width, C, of the backing layer 610 is B. The width, B, of thebacking layer 610 in the fin-forming region 620, is approximately 1 cm.In alternate embodiments, the width, B, of the backing layer 610 in thefin forming region 620 ranges between approximately 2 mm andapproximately 6 cm. In other embodiments, however, the fin formingregion 620 ranges between 2 mm and the width, C, of the backing layer610. In other embodiments, the fin-forming region 620 is longer than thewidth, C, of the backing layer 610.

[0274] The variation in width between the areas inside and outside theindented fin-forming region 620, forms the first edge 690 and a secondedge 691 of the fin-forming region 620.

[0275] A first notch 136(a) is formed on the distal end 137 the firstedge 690 of the fin-forming region 620 of the backing layer 130. Asecond notch 136(b) is formed on the distal end 137 the second edge 691of the fin-forming region 620 of the backing layer 130.

[0276] The backing layer 610 in this embodiment is formed of flexiblesilicone. In alternative embodiments the backing layer 610 is formed ofany bio-compatible, flexible polymeric material.

[0277]FIG. 22(b) illustrates a top plan view of the lead electrodeassembly 100 of this embodiment. The backing layer 610 is attached tothe electrode 107, so that the first edge 690 and a second edge 691 ofthe fin-forming region 620 of the backing layer 610 meet. This causesthe backing layer 610 in the first fin area 612 and the second fin area615 to fold together to form a fin 120.

[0278] The first notch 136(a) and second notch 136(b) formed on thedistal end 137 the first edge 690 and second edge 691 of the fin-formingregion 620 of the backing layer 130 meet to form a notch 136 on thedistal end 137 of the backing layer, through which the lead fastener 146rises. Stitching 660 holds the backing layer to the electrode 107.

[0279]FIG. 22(c) illustrates a side plan view of the lead electrodeassembly 100 of this embodiment. Stitching 660 holds the first fin area612 and a second fin area 615 of the backing layer 610 together to formthe fin 120. FIG. 22(d) illustrates a front plan view of the leadelectrode assembly 100 of this embodiment. In one embodiment, the fin120 is reinforced with a layer of Dacron® polymer mesh positionedbetween the first fin area 612 and a second fin area 615. In anotherembodiment, the Dacron® polymer mesh is attached only to either firstfin area 612 or the second fin area 615. In other embodiments, the fin120 is similarly reinforced with a layer of any polymeric material.

[0280] FIGS. 22(e) and 22(f) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiment illustrated in FIGS. 22(a)-22(d). The backing layer 610is substantially similar to the backing layer 610 illustrated in FIG.22(a). The backing layer 610 in this embodiment, however, is cut alongline 617. The fin 120 of this embodiment comprises a proximal edge 129.The proximal edge 129 of the fin 120 is slope-shaped. The sloped shapecan reduce the resistance offered by the tissue of the patient as itslides against the fin 120 during the insertion of the lead electrodeassembly 100 into the patient.

[0281] FIGS. 23(a) and 23(b) illustrate a property of the embodiment ofthe lead electrode assembly 100 illustrated in FIGS. 22(e) and 22(f).The backing layer 610 is flexible, such that the substantially planarfin 120 formed therefrom is flexible and able to fold. Because theability of the fin 120 to fold effectively reduces its appendage height,it may make the fin more comfortable to the patient after it isimplanted.

[0282]FIG. 23(a) shows fin 120 in an upright condition. When pressure isapplied perpendicular to the first surface 131 of backing layer in thefirst fin area 612, along line 677 for example, the fin 120 folds asshown in FIG. 23(b). When the fin 120 folds, its appendage height,HAppendage, is reduced. This can be seen by a comparison between FIG.23(a) and FIG. 23(b).

[0283] The backing layer 610 in this embodiment is formed of a polymericmaterial. In an alternative embodiment, the backing layer 610 is formedof any bio-compatible, flexible polymeric material.

[0284] FIGS. 24(a)-24(c) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiment illustrated in FIGS. 22(a)-22(d).

[0285] As shown in FIG. 24(a), however, the material from the first finarea 612 and the second fin area 615 of the backing layer 610 is notfastened together with stitching 660 in this embodiment. The resultingappendage 118 is formed in the shape of a tube.

[0286] In alternate embodiments, the backing layer 610 is coupled to theelectrode 107 such that the material from the first fin area 612 and thesecond fin area 615 of the backing layer 610 does not touch except atthe dividing line 617 between the first fin area 612 and the second finarea 615. The separation between the first fin area 612 and the secondfin area 615 of the backing layer 610 can allow the appendage 118 ofthis embodiment to be highly flexible. This flexibility can reduce theresistance offered by the tissue of the patient as it slides against theappendage 118 during the insertion of the lead electrode assembly 100into the patient.

[0287]FIG. 24(b) illustrates a side plan view of the embodimentillustrated in FIG. 24(a). The appendage 118 of this embodimentcomprises a proximal edge 129. The proximal edge 129 of the appendage118 is slope-shaped. The sloped shape can reduce the resistance offeredby the tissue of the patient as it slides against the appendage 118during the insertion of the lead electrode assembly 100 into thepatient.

[0288] In alternate embodiments, the proximal edge 129 of the tubeformed by the appendage 118 is closed. In one embodiment, the proximaledge 129 of the appendage 118 is closed by a cap (not shown). In anotherembodiment, the proximal edge 129 of the appendage 118 is closed withstitching placed between the first fin area 612 and the second fin area615 only at the proximal edge 129 of the appendage 118. In anotherembodiment, the proximal edge 129 of the appendage 118 is closed by anyother means known in the art for this purpose.

[0289]FIG. 24(b) illustrates a top plan view of the embodimentillustrated in FIGS. 24(a)-24(b).

[0290] FIGS. 25(a)-25(d) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiment illustrated in FIGS. 15(a)-15(b). The backing layer 130of this embodiment, however, lacks an integrated fin 120.

[0291]FIG. 25(a) illustrates a front plan view of the lead electrodeassembly. The fin 120 in this embodiment comprises a fin head 700 andflexible joining material 702.

[0292] The fin head 700 comprises a rectangular sheet having a firstface 705, a second face 706, a first end 710 and a second end 712. Thefin head 700 further comprises a height measured along the first face705 between the first end 710 and the second end 712 and a lengthmeasured perpendicular to its height.

[0293] The fin head 700 is made of rigid silicone, which has a highdurometer. In alternate embodiments, the fin head 700 is composed of anyrigid bio-compatible material, such as a rigid bio-compatible polymericmaterial.

[0294] The flexible joining material 702 comprises a rectangular sheethaving a first face 720, a second face 721, a first end 718 and a secondend 719. The flexible joining material 702 further comprises a heightmeasured along the first face between the first end 718 and the secondend 719. The flexible joining material 702 also comprises a lengthmeasured perpendicular to its height. The length of the flexible joiningmaterial 702 is the same as the length of fin head 700.

[0295] The second end 712 of the second face 706 of the fin head 700 isattached to the first end 718 of the first face 720 of the flexiblejoining material 702. The fin head 700 is attached to the flexiblejoining material 702 with stitching 725. The second end 719 of the firstface 720 of the flexible joining material 702 is attached to the firstsurface 131 of the backing material 130. The flexible joining material702 is attached to the backing material 130 with stitching 730.

[0296] The flexible joining material 702 is made of flexible silicone.It will be recognized by one skilled in the art, however, that theflexible joining material 702 may be made from many other flexiblematerials, such as a flexible polymeric material.

[0297]FIG. 25(b) illustrates a property of the fin 120. When pressure isapplied perpendicular to the first surface 705 of the fin head 205, thefin 120 folds as shown. When the fin 120 folds, its appendage height,H_(Appendage), is reduced. This can be seen by a comparison between FIG.25(a), which shows the fin 120 in an upright position and FIG. 25(b)which shows the fin 120 in a folded position.

[0298]FIG. 25(c) illustrates a top planar view of the lead electrodeassembly 100 of the embodiment illustrated in FIGS. 25(a) and 25(b).Neither the corners of the electrode 107 nor the corners 735 of thebacking layer 130 of this embodiment are rounded. In an alternateembodiment, both the corners of the electrode 107 and the corners 735 ofthe backing layer 130 of this embodiment are rounded.

[0299]FIG. 26 illustrates an alternative embodiment of the leadelectrode assembly 100. This embodiment is substantially similar to theembodiment illustrated in FIGS. 25(a)-25(d). The backing layer 130 ofthis embodiment, however, lacks a fin head 700 and flexible joiningmaterial 702.

[0300] Moreover, the appendage 118 in this embodiment comprises a tube740 having an interior 755, an exterior 756, a proximal end 757 and adistal end 758. The tube comprises a sheet of material 750. The sheet ofmaterial 750 is substantially rectangular having a first pair of sides751, a second pair of sides 752, a first surface 753 and a secondsurface 754.

[0301] The sheet of material 750 is folded so that its first pair ofsides 751 abut each other. The folded sheet of material 750 forms a tube740. The first surface 753 of the sheet of material 750 faces theinterior 755 of the tube 740. The second surface 754 of the sheet ofmaterial 750 faces the exterior of the tube 756. In folding the sheet ofmaterial 750 so that the first pair of sides 751 abut each other, thesecond pair of sides 752 of the sheet of material 750 are folded in acircular shape to form the proximal end 757 and distal end 758 of thetube 740. This results in the tube 740 having a cylindrical shape. Thediameter of the circular proximal end 757 and distal end 758 of the tube756 is approximately 5 mm. In alternate embodiments, the diameter rangebetween approximately 1 mm and approximately 10 mm. The length of thetube 756 as measured between the proximal end 757 and distal end 758 ofthe tube 756 is approximately 1 cm. In alternate embodiments, length ofthe tube 756 ranges between approximately 2 mm and approximately 6 cm.In one embodiment, the tube 756 is substantially as long as theelectrode 107.

[0302] The second surface 754 of the sheet of material 750 is attachedto the first surface 131 of the backing layer 130. The first pair ofsides 751 of the sheet of material 750 are attached to the backing layer130 with stitching 760.

[0303] In alternate embodiments, the proximal end 757 of the tube 740 isclosed. In one embodiment, the proximal end 757 of the tube 740 isclosed by a cap (not shown). In another embodiment, the proximal end 757of the tube 740 is closed by holding one of the second pair of sides 752of the sheet of material 750 closed with stitching. In anotherembodiment, the proximal end 757 of the tube 740 is closed by any othermeans known in the art for this purpose.

[0304] It should be noted that the appendage 118 in some alternativeembodiments comprises a tube with a shape other than a cylinder. Anexample of a tube with a shape other than cylindrical is illustratedbelow in FIG. 27.

[0305]FIG. 27 illustrates an alternative embodiment of the leadelectrode assembly 100. This embodiment is substantially similar to theembodiment illustrated in FIG. 26. The tube 740 comprising a sheet ofmaterial 750, however, is absent from this embodiment.

[0306] Moreover, the appendage 118 of this embodiment comprises a tube770 having an interior 755 an exterior 756, a proximal end 757 and adistal end 758. The tube comprises a first sheet of material 775, asecond sheet of material 776 and a third sheet of material 777. Thefirst sheet of material 775, the second sheet of material 776 and thethird sheet of material 777 are all substantially rectangular in shape.Each comprises a first pair of sides 784, a second pair of sides 786, afirst surface 788 and a second surface 789. The first pair of sides 784of each sheet of material are parallel to each other. In anotherembodiment, the first pair of sides 784 of each sheet of material arenon-parallel. The second pair of sides 786 of each sheet of material areparallel to each other. In another embodiment, the second pair of sides786 of each sheet of material are non-parallel.

[0307] The first pairs of sides 784 of each sheet of material areattached to the first pair of sides 784 of the other sheets of material.In this way the second pair of sides 786 of the first sheet of material775, the second sheet of material 776 and the third sheet of material777 form a triangular shaped proximal end 757 and distal end 758 of thetube 770. The sheets of material are attached to each other such thatthe second surface 789 of each sheet of material faces the interior 755of the tube 770. The sheets of material are attached to each other withstitching 791.

[0308] The height of the tube 770 is approximately 5 mm. In alternateembodiments, the height ranges between approximately 1 mm andapproximately 10 mm. The length of the tube 770 as measured between theproximal end 757 and distal end 758 of the tube 770 is approximately 1cm. In alternate embodiments, length of the tube 770 ranges betweenapproximately 2 mm and approximately 6 cm. In one embodiment, the tube770 is substantially as long as the electrode 107.

[0309] The second sheet of material 776 is attached to the backing layer130 with stitching 790. The first surface 788 of the second sheet ofmaterial 776 is positioned next to the first surface 131 of the backinglayer 130.

[0310] In alternate embodiments, some or all of the sheets of materialare reinforced with a layer of Dacron® polymer mesh. In one embodiment,the Dacron® polymer mesh is attached to the first surface 788 of eachsheet of material. In another embodiment, the Dacron® polymer mesh isattached to the second surface 789 of each sheet of material. In anotherembodiment, the sheets of material are similarly reinforced with a layerof any polymeric material.

[0311] In alternate embodiments, the proximal end 757 of the tube 770 isclosed. In one embodiment, the proximal end 757 of the tube 770 isclosed by a cap. In another embodiment, the proximal end 757 of the tube770 is closed by holding the sides 786 of the first sheet of material775, the second sheet of material 776 and the third sheet of material777 that form the proximal end 757 of the tube 770 together withstitching. In another embodiment, the proximal end 757 of the tube 770is closed by any other means known in the art for this purpose.

[0312] FIGS. 28(a)-28(d) illustrate various possible positions for theappendage 118 relative to the lead 21 of the lead electrode assembly100. Additionally, up to this point, all embodiments of the electrode107 illustrated and discussed have had a rectangular shape. Thesefigures illustrate alternative embodiments with electrodes 107 ofdifferent shapes.

[0313] At this point, it is useful to set out two definitions in orderto discuss the possible orientation of appendages 118.

[0314] The interface line is defined as the center line of the appendage118 as traced on the electrode 107. FIG. 28(a) illustrates the interfaceline 800 of the appendage 118 of a lead electrode assembly 100.

[0315] The line of the lead is defined as the line along which the lead21 of the lead electrode assembly 100 enters the lead fastener 146. Theline of the lead 805 of line 21 is shown as it enters the lead fastener146 (in phantom). As the lead 21 approaches the lead fastener 146, theclosest section 807 of the lead 21 forms the line of the lead. When thelead 21 is not bent, the entire lead 21 lies along the line of the lead.

[0316]FIG. 28(b) illustrates an embodiment wherein the lead 21 is notbent and the entire lead 21 lies along the line of the lead 805.

[0317] The electrode length, LElectrode, is the length of the electrode107 as measured along the interface line 800.

[0318] In the embodiments of the lead electrode assembly 100 shown inFIGS. 28(b) and 28(c), the interface line 800 is the same line as theline of the lead 805. In the embodiment shown in FIG. 28(a) theinterface line 800 is parallel with the line of the lead 805.

[0319] In the embodiment of the lead electrode assembly 100 shown inFIG. 28(d), the interface line 800 intersects the lead fastener 146(phantom view).

[0320] FIGS. 28(e)-28(h) show various additional electrode shapesdisposed in various lead electrode assemblies 100. The electrode shapesare not limited, however, to the shapes specifically illustrated.

[0321] The electrode 204 depicted in FIG. 28(e) has a “thumbnail” shape.The proximal end 104 of this electrode 107 is generally rounded. As theelectrode 107 moves distally along its length, the conductive surfaceterminates at the distal end 103 of the electrode 107.

[0322] An ellipsoidal shaped electrode 107 is depicted in FIG. 28(f).The proximal end 104 of the ellipsoidal shaped electrode 107 isgenerally rounded. As the ellipsoidal shaped electrode 107 movesdistally along its length, the conductive surface terminates in arounded distal end 103.

[0323] A circular shaped electrode 107 is illustrated in FIG. 28(g).

[0324] A triangular shaped electrode 107 is depicted in FIG. 28(h).Triangular shaped electrodes 107 also incorporate electrodes that aresubstantially triangular in shape. In particular to FIG. 28(h), thecorners of the triangular shaped electrode 107 are rounded.

[0325] Several lead electrode assembly manipulation tools 927 have beendeveloped to manipulate the lead electrode assemblies during theirsurgical implantation.

[0326]FIG. 29 illustrates an embodiment of a lead electrode assemblymanipulation tool 927. The lead electrode assembly manipulation tool 927comprises an enhanced hemostat 930 used to manipulate lead electrodeassemblies 100 comprising an eyelet during their implantation inpatients.

[0327] The enhanced hemostat 930 comprises the following components: ahemostat having a first prong 931, a second prong 932, a hinge 939 andan eyelet pin 940. The first prong 931 is attached to the second prong932 by the hinge 939. The eyelet pin is attached to the second prong932.

[0328] The first prong 931 comprises a first end 933 and a second end934. The second prong 932 comprises a first end 935 and a second end936. The first prong and second prong are approximately 75 cm long andcurved with a radius of approximately 30 cm. In alternate embodiments,the curvature of the hemostat does not have a radius of approximately 30cm, but instead approximates the curvature of the thorax of a patient.In one embodiment, the curvature of the hemostat approximates thecurvature of the thorax of a patient along a subcutaneous path takenfrom the anterior axillary line, posteriorly toward the spine.

[0329] The first prong 931 is pivotally attached to the second prong 932by the hinge 939. The hinge is attached to the first prong 931approximately 10 cm from the first end 933. In this embodiment, thehinge is attached to the second prong 932 approximately 10 cm from thesecond end 935.

[0330] The eyelet pin 940 can be inserted through the eyelet 301 of afin 120 of the lead electrode assembly 100 such as the lead electrodeassembly 100 discussed with reference to FIG. 17(a)17(g) as a means ofcapturing the lead electrode assembly 100 prior to its implantation in apatient.

[0331] The eyelet pin 940 is a cylindrical member having a first end 941and a second end 942. In an alternate embodiment, the eyelet pin 940 isa hook-shaped member. The diameter of the cylinder is approximately 2mm. In alternate embodiments, the diameter of the cylinder ranges fromapproximately 1 mm to approximately 5 mm. The length of the eyelet pin940 is approximately 8 mm. In alternate embodiments, the length of theeyelet pin 940 ranges from approximately 4 to approximately 15 mm.

[0332] The first end of the eyelet pin 940 is attached to the secondprong 932, approximately 8 mm from the second end 936 of the secondprong 932. In alternate embodiments, the eyelet pin 940 is attached tothe second prong 932 at various lengths from the second end 936 of thesecond prong 932.

[0333] The eyelet pin 940 is attached to the second prong 932 in anorientation perpendicular to the length of the second prong 932. Theeyelet pin 940 is attached to the second prong 932 so that it extendsaway from the second end 934 of the first prong 931.

[0334] In this embodiment, all of the components are made of stainlesssteel. In an alternative embodiment, some or all of the components arecomposed metals other than stainless steel or are composed of apolymeric material.

[0335] We now turn to a discussion of the positions of the componentsthat comprise an entire S-ICD system including the lead electrodeassembly 100 when it is implanted in a patient.

[0336] FIGS. 30(a) and 30(b) illustrate an embodiment of the S-ICDsystem implanted in a patient as a means of providingcardioversion/defibrillation energy.

[0337]FIG. 30(a) is a perspective view of a patient's ribcage with animplanted S-ICD system. The S-ICD canister 11 is implantedsubcutaneously in the anterior thorax outside the ribcage 1031 of thepatient, left of the sternum 920 in the area over the fifth rib 1038 andsixth rib 1036. The S-ICD canister 11, however, may alternately beimplanted anywhere over the area between the third rib and the twelfthrib. The lead 21 of the lead electrode assembly 100 is physicallyconnected to the S-ICD canister 11 where the transthoracic cardiacpacing energy or effective cardioverion/defibrillation shock energy(effective energy) is generated. The term “effective energy” as used inthis specification can encompass various terms such as field strength,current density and voltage gradient.

[0338] The lead 21 of the lead electrode assembly 100 travels from theS-ICD canister 11 to the electrode 107, which is implantedsubcutaneously in the posterior thorax outside the ribcage 1031 of thepatient in the area over the eighth rib 1030 and ninth rib 1034. Theelectrode 107, may alternately be implanted subcutaneously anywhere inthe posterior thorax outside the ribcage 1031 of the patient in the areaover the third rib 1030 and the twelfth rib 1034. The bottom surface 115of the electrode 107 faces the ribcage. The electrode or active surface15 (phantom view) of the canister 11 also faces the ribcage.

[0339]FIG. 30(b) is a cross-sectional side plan view of the patient'srib cage. Here it is seen that the lead 21 travels around thecircumference of the thorax, in the subcutaneous layer beneath the fat1050 between the outside of the ribcage 1031 and the skin 1055 coveringthe thorax.

[0340] We now turn to a discussion of a method by which the leadelectrode assembly 100 of the S-ICD system is implanted in a patientusing a standard hemostat as well as the enhanced hemostat describedabove. FIG. 31 and FIGS. 32(a)-32(d) illustrate aspects of this method.

[0341] In operation, as seen in FIG. 31, an incision 905 is made in thepatient 900 in the anterior thorax between the patient's third and fifthrib, left of the sternum 920. The incision can alternately be made inany location between the patient's third and twelfth rib. The incisioncan be made vertically (as shown), horizontally or angulated. In orderto minimize scarring, the incision can be made along Langher's lines.

[0342]FIG. 32(a) shows a bottom view cross-section of the patient 900,along the line 32(a) shown in FIG. 31. A hemostat 930, with prongs 932is introduced into the incision 905. The hemostat 930 is inserted withits prongs together without anything gripped between them. The prongs932 of the hemostat 930 are pushed through the fat 1050 between the skin1055 of the thorax and the ribcage 1031 to create a subcutaneous path1090.

[0343] The prongs 932 of the hemostat 930 can alternately be pushedbeneath the fat 1050 that lies between the skin 1055 of the thorax andthe ribcage 1031 to create a subcutaneous path 1090 between the fat 1050and the ribcage 1031.

[0344] The hemostat is moved around the ribcage 1031 until thesubcutaneous path 1090 reaches within approximately 10 cm of the spine1035 between the eighth rib 1030 and ninth rib 1034 (this location isbest seen in FIG. 30(a)) between the skin 1055 and the ribcage 1031. Thesubcutaneous path 1090 can alternately be made to reach any locationbetween the skin 1055 and the ribcage 1031 between the patient's thirdand twelfth rib. The hemostat 930 is then withdrawn. Alternately, thehemostat 930 can be moved around the ribcage 1031 until the subcutaneouspath 1090 terminates at a termination point 1085 at which a line 1084drawn from the termination point 1085 to the incision 905 wouldintersect the heart 910.

[0345] Next, as shown in FIG. 32(b), the appendage 118 of a leadelectrode assembly 100, is squeezed between the tongs 932 of a hemostat930.

[0346] As shown in FIG. 32(c), the lead electrode assembly 100 andhemostat tongs 932 are introduced to the subcutaneous path 1090 andpushed through the subcutaneous path until the lead electrode assembly100 reaches the termination point 1085 of the path. The appendage 118 ofthe lead electrode assembly 100 is then released from the tongs 932 ofthe hemostat 930. The hemostat 930 is then withdrawn from thesubcutaneous path 1090.

[0347] In an alternative method, the enhanced hemostat 930 seen in FIG.29 is used to introduce the lead electrode assembly 100 into thesubcutaneous path 1090 created as discussed above. After thesubcutaneous path 1090 is created, the lead electrode assembly 100 isattached to the enhanced hemostat 930 as shown in FIG. 32(d). Eyelet pin1108 is inserted through the eyelet 301 in the fin 120 of the leadelectrode assembly 100. The enhanced hemostat 930 is then used tointroduce the lead electrode assembly 100 into the subcutaneous path1090, as shown in FIG. 32(c). The lead electrode assembly 100 is thenmoved through the subcutaneous path 1090 until the electrode 107 reachesthe end of the path 1085. The enhanced hemostat 930 is then moved untilthe lead electrode assembly 100 is released from the eyelet pin 940. Theenhanced hemostat 930 is then withdrawn from the subcutaneous path 1090.

[0348] FIGS. 33(a)-33(c) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiments illustrated in FIGS. 17(a)-17(g). The backing layer 130of this embodiment, however, lacks an integrated fin tab 180. Moreover,the appendage 118 of the lead electrode assembly 100 of this embodimentcomprises a rail 1100.

[0349]FIG. 33(a) illustrates the rail 1100 of the lead electrodeassembly 100 of this embodiment. The rail 1100 is a member attached tothe electrode 107 that can be captured by a lead electrode assemblymanipulation tool and used to precisely locate the electrode 107 duringits surgical implantation within the patient. The rail 1100 comprisesthree sections: a foundation 1105, a riser 1110 and a head 1115. Thefoundation 1105 is separated from the head 1115 by the riser 1125.

[0350] The foundation 1105 comprises a flat, substantially planarmember, comprising a first pair of sides 1106 and a second pair of sides1107. The first pair of sides 1106 of the foundation 1105 aresubstantially linear and substantially parallel. In an alternateembodiment, the first pair of sides 1106 of the foundation 1105 areneither linear nor parallel. The length of the first pair of sides 1106of the foundation 1105 is approximately 2 cm. In alternate embodiments,the length of the first pair of sides 1106 of the foundation 1105 rangesfrom approximately 2 mm to approximately 6 cm. In an alternateembodiment, the first pair of sides 1106 of the foundation 1105 are aslong as the electrode 107 (not shown) of the lead electrode assembly 100(not shown).

[0351] The second pair of sides 1107 of the foundation 1105 aresubstantially linear and substantially parallel. In an alternateembodiment, the second pair of sides 1107 of the foundation 1105 areneither linear nor parallel. The length of the second pair of sides 1107of the foundation 1105 is approximately 1 cm. In alternate embodiments,the length of the second pair of sides 1107 of the foundation 1105ranges from approximately 0.5 cm to approximately 3 cm.

[0352] The foundation 1105 further comprises a top surface 1120 and abottom surface 1121. The foundation 1105 has a thickness, measured asthe distance between the top surface 1120 and the bottom surface 1121.The thickness of the foundation 1105 is 2 mm. In alternate embodiments,the thickness of the foundation 1105 ranges between approximately 1 mmand approximately 5 mm.

[0353] Turning now to the riser 1110, the riser 1110 comprises a flat,substantially planar protrusion from the top surface 1120 of thefoundation 1105 of the rail 1100. The riser comprises a first face 1125,a second face 1126, a top 1127, a bottom 1128, a proximal end 1123 and adistal end 1124. The first face 1125 and second face 1126 are parallelto each other and perpendicular to the top surface 1120 of thefoundation 1105. The first face 1125 and a second face 1126 of the riser1110 are parallel to the first pair of sides 1106 of the foundation1105. The bottom 1128 of the riser 1110 joins the foundation 1105 in aposition centered between the first pair of sides 1106 of the foundation1105. The proximal end 1123 of the riser 1110 and the distal end 1124 ofthe riser 1110 are parallel to each other and perpendicular to the topsurface 1120 of the foundation 1105. In other embodiments, the proximalend 1123 of the riser 1110 and the distal end 1124 of the riser 1110 arenot parallel to each other.

[0354] In one embodiment, the proximal end 1123 of the riser 1110 is notperpendicular the top surface 1120 of the foundation 1105. Instead, theproximal end 1123 of the riser 1110 is sloped, so that the proximal end1123 and the distal end 1124 of the riser 1110 are closer at the top1127 of the riser 1110 than at the bottom 1128 of the riser. A slantedproximal end 1123 make the rail 1100 of the lead electrode assembly 100offer less resistance against the tissues of the patient duringinsertion into the patient.

[0355] The height of the riser, H_(Riser), is measured as the distancebetween the top surface 1120 of the foundation 1105 to the head 1115,perpendicular to the top surface 1120 of the foundation 1105. The heightof the riser is approximately 5 mm. In alternate embodiments, the heightof the riser ranges from approximately 1 mm to approximately 10 mm.

[0356] The riser 1110 has a width, measured as the distance between thefirst face 1125 and the second face 1126. The width of the riser 1110 is2 mm. In alternate embodiments, the width of the riser 1110 ranges fromapproximately 1 mm to approximately 6 mm.

[0357] Turning now to the head 1115, the head 1115 is a flat,substantially planar member. The head 1115 comprises a first pair ofsides 1136, a second pair of sides 1137, a top surface 1116 and a bottomsurface 1117 (not shown). The first pair of sides 1136 and the secondpair of sides 1137 of the head 1115 are substantially linear andsubstantially parallel. In an alternate embodiment, the first pair ofsides 1136 of the head 1115 are neither linear nor parallel. In analternate embodiment, the second pair of sides 1137 of the head 1115 areneither linear nor parallel.

[0358] The length of the first pair of sides 1136 of the head 1115 isequal to the length of the first pair of sides 1106 of the foundation1105. In alternate embodiments, the length of the first pair of sides1136 of the head 1115 is unequal to the length of the first pair ofsides 1106 of the foundation 1105. The length of the second pair ofsides 1137 of the head 1115 is approximately 5 mm. In alternateembodiments, the length of the second pair of sides 1137 of the head1115 ranges from approximately 3 mm to approximately 10 mm.

[0359] The bottom surface 1117 of the head 1115 joins the top 1127 ofthe riser 1110 opposite the foundation 1105 of the rail 1100. The topsurface 1116 and the bottom surface 1117 of the head 1115 are parallelto the top surface 1120 of the foundation 1105. In an alternateembodiment, the top surface 1116 and the bottom surface 1117 of the head1115 are not parallel to the top surface 1120 of the foundation 1105.

[0360] The head 1115 has a thickness, measured as the distance betweenthe top surface 1116 and the bottom surface 1117 of the head 1115. Thethickness of the head 1115 is approximately 2 mm. In alternateembodiments, the thickness of the head ranges between approximately 2 mmand approximately 10 mm.

[0361] The foundation 1105, the head 1115 and the riser 1110 are made ofstainless steel. In alternate embodiments, some or all of the sectionsof the rail 1100 are made of metals other than stainless steel. Inalternate embodiments, some or all of the sections of the rail 1100 aremade of a polymeric material wherein the polymeric material is selectedfrom the group consisting essentially of a polyurethane, a polyamide, apolyetheretherketone (PEEK), a polyether block amide (PEBA), apolytetrafluoroethylene (PTFE), a silicone and mixtures thereof.

[0362] The foundation 1105, the head 1115 and the riser 1110 aremachined from the same piece of material. In an alternate embodiment,some or all of the sections are formed independently and welded to theothers.

[0363] Turning in detail to FIG. 33(b), the position of the rail 1100within the lead electrode assembly 100 will be discussed. The rail 1100is positioned so that its bottom surface 1121 is adjacent to and coversa region of the first surface 131 of the backing layer 130. The rail iscentered between the first side 133 and second side 134 of the backinglayer 130. In an alternate embodiment, the rail is not centered betweenthe first side 133 and second side 134 of the backing layer 130.

[0364] In an alternate embodiment, there is no backing layer 130 and therail 1100 is positioned so that its bottom surface 1121 is adjacent tothe top surface 110 of the electrode 107.

[0365] Turning now to the electrode 107 of this embodiment, theelectrode 107 is the same shape and size as the electrode 107 discussedwith reference to FIGS. 17(a)-(g). In alternative embodiments, thelength of the first pair of sides 108 (not shown) and second pair ofsides 109 (not shown) of the electrode 107 range independently betweenapproximately 1 cm and approximately 5 cm.

[0366] Turning now to the molded cover 220, the skirt 222 of the moldedcover 220 partially covers the bottom surface 115 of the electrode 107as discussed with reference to FIG. 17(d). The molded cover 220 furthersubstantially covers the first surface 131 of the backing layer 130. Themolded cover 220 does not cover the first surface 131 of the backinglayer 220 in the region in which the bottom surface 1121 of the rail1100 is adjacent to the backing layer 130. Instead, the molded cover 220in this region substantially covers the top surface 1120 of the rail1100. The molded cover 220 abuts the first face 1125 and second face1126 of the riser 1110 of the rail 1100.

[0367] Turning to FIG. 33(c), the position of the lead 21 and theappendage 118 will now be discussed. The interface line 800 of theappendage 118 and the line of the lead 805 are the same line. In analternate embodiment, interface line 800 of the appendage 118 and theline of the lead 805 are not the same line. The line of the lead 805 iscentered between the first pair of sides 108 (phantom view) of theelectrode 107 (phantom view). In an alternate embodiment, the line ofthe lead 805 is not centered between the first pair of sides 108 of theelectrode 107.

[0368]FIG. 34 illustrates an alternative embodiment of the leadelectrode assembly 100. This embodiment is substantially similar to theembodiment illustrated in FIGS. 33(a)-33(c). In this embodiment,however, the dimensions of the electrode 107 are different from those ofthe embodiment illustrated in FIGS. 33(a)-33(c).

[0369] The first pair of sides 108 of the electrode 107 (phantom view)are approximately b 2.4 cm in length. The second pair of sides 109 ofthe electrode 107 are approximately 4 cm in length. In alternativeembodiments, the length of the first pair of sides 108 and second pairof sides 109 of the electrode 107 range independently betweenapproximately 1 cm and approximately 5 cm.

[0370] The interface line 800 of the rail 1100 is parallel to the lineof the lead 805. In an alternate embodiment, the interface line 800 ofthe rail 1110 is not parallel to the line of the lead 805. The interfaceline 800 of the rail 1100 is centered between the first pair of sides108 of the electrode 107. In an alternate embodiment, the interface line800 of the rail 1100 is not centered between the first pair of sides 108of the electrode 107.

[0371] The line of the lead 805 is not centered between the first pairof sides 108 of the electrode 107. Because the lead 805 is not centeredbetween the first pair of sides 108 of the electrode 107, the lead rail1110 may be more easily accessed by a lead electrode manipulation tool(not shown). In an alternate embodiment, the line of the lead 805 iscentered between the first pair of sides 108 of the electrode 107.

[0372]FIG. 35 illustrates a lead electrode assembly manipulation tool927 useful for manipulating a lead electrode assembly (not shown) havingan appendage 118 comprising a rail 1100 during the implantation of thelead electrode assembly 100 in a patient. Examples of such leadelectrode assembly 100 embodiments are shown in FIGS. 33(a)-33(c) and34.

[0373] The lead electrode assembly manipulation tool 927 comprises ahandle 1142, a rod 1144 and a rail fork 1146. The handle 1142 isconnected to the rod 1144. The rail fork 1146 is also connected to therod 1144.

[0374] The rod 1144 is a cylindrical member with a diameter ofapproximately 4 mm, approximately 25 cm in length, having a proximal end1147 and a distal end 1148. The rod 1144 is curved with a radius ofapproximately 20 cm.

[0375] The rod is made of steel. In other embodiments, the rod iscomposed of titanium, a polymeric material or any other materialsuitable for this purpose.

[0376] The handle 1142 is a cylindrical member with a diameter sized tofit comfortably in the palm of a surgeon's hand. The rod is connected tothe proximal end 1147 of the rod 1144. In an alternate embodiment, thehandle 1142 is not cylindrical. In an alternate embodiment, the handle1142 has ergodynamic contours.

[0377] The handle is made of polyurethane. In an alternate embodiment,the handle is made of any metal, or any polymeric material suitable forthis purpose.

[0378] Turning now to FIG. 35(b), the rail fork 1146 is attached to thedistal end 1148 of the rod 1144. The rod further comprises a slot 1162in its distal end. The rail fork comprises a pair of tines 1151separated by a gap 1153 and a tine base 1160 having a tang 1161.

[0379] Each of the pair of tines 1151 has a proximal end 1154 and adistal end 1155. The proximal ends 1154 of the pair of tines 1151 areattached to the tine base 1160. Each of the pair of tines 1151 has asubstantially rectangular form with straight inner sides 1156 andstraight outer sides 1157. The distal ends 1155 of each of the pair oftines 1151 are rounded. The length of the pair of tines 1151, measuredfrom the distal end 1155 to the proximal end 1154, is substantiallyequal to the length of the first pair of sides 1106 of the rail 1100 ofthe lead electrode assembly 100. In alternate embodiments, the length ofthe pair of tines 1151 is substantially greater than or less than thelength of the first pair of sides 1106 of the rail 1100.

[0380] The pair of tines 1151 are separated by a gap 1153 formed by theinner sides 1156 of the pair of tines 1151 and the tine base 1160.

[0381] The pair of tines 1151 and the tine base 1160 comprising the railfork 1146 are punched from a single sheet of steel having a thickness ofapproximately 3 mm. In other embodiments, the rail fork 1146 is composedof titanium, a polymeric material or any other material suitable forthis purpose. In one embodiment, the handle 1142, the rod 1144 and therail fork 1146 are all made from the same piece of material.

[0382]FIG. 35(c) illustrates a side plan view of the lead electrodeassembly manipulation tool 927. The rod 1144 further comprises a slot1162 in its distal end 1148. The tine base 1160 connects the pair oftines 1151 to the distal end 1148 of the rod 1144. The tine base 1160comprises a tang 1161 (phantom view). The tang 1161 is inserted in theslot 1162 in the rod 1144. The tang 1161 is welded in the slot 1162 ofthe rod 1144.

[0383] We now turn to a description of the use of the lead electrodeassembly manipulation tool 927 in the implantation of a lead electrodeassembly 100 into a patient.

[0384] As discussed with reference to FIG. 31, an incision 905 is madein the patient 900. As discussed with reference to FIG. 32(a), asubcutaneous path 1090 is created in the patent 900 with a hemostat 932.

[0385] As shown in FIG. 35(d), the lead electrode assembly 100 is thencaptured by the lead electrode assembly manipulation tool 927. The rail1110 of the lead electrode assembly 100 is inserted into the rail fork1146 of the lead electrode assembly manipulation tool 927. The riser1110 (phantom view) of the rail is placed into the gap 1153 between thepair of tines 1151 of the rail fork 1146. The pair of tines 1151 fitbetween the bottom surface 1117 of the head 1115 of the rail 1100 andthe molded cover 220. The rail 1100 is slid toward the proximal end 1155of the pair of tines 1151 until the riser 1110 of the rail 1100 reachesthe tine base 1160 of the rail fork 1146. The lead 21 of the leadelectrode assembly 100 can then be pulled in toward the handle 1142 ofthe lead electrode assembly manipulation tool 927 until it is taught.This acts to prevent the rail 1100 of the lead electrode assembly 100from sliding toward the distal end 1151 of the pair of tines 1151 of therail fork 1146.

[0386] As discussed with reference to FIG. 32(c), the lead electrodeassembly manipulation tool 927 may then be used to place the leadelectrode assembly 100 into the incision 905 of the patient 900 and usedto move the electrode 107 to the termination point 1085 of thesubcutaneous path 1090.

[0387] The lead electrode assembly 100 is then released from the leadelectrode assembly manipulation tool 927. To achieve this, the lead 21of the lead electrode assembly 100 is released so that the pair of tines1151 of the rail fork 1146 of the lead electrode assembly manipulationtool 927 can slide relative to the rail 1100 of the lead electrodeassembly 100. The lead electrode assembly manipulation tool 927 may thenbe extracted from the subcutaneous path 1090, leaving the lead electrodeassembly 100 behind.

[0388] FIGS. 36(a)-36(b) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiments illustrated in FIGS. 17(a)-17(g). The backing layer 130of this embodiment, however, lacks an integrated fin tab 180. Moreover,the lead electrode assembly 100 of this embodiment further comprises apocket 1300.

[0389]FIG. 36(a) illustrates a cross-sectional side plan view of thisembodiment. The pocket 1300 comprises a layer of material 1315 andstitching 360. The pocket further comprises an interior 1305 and anopening 1310. The layer of material 1315 is attached to the molded cover220 with the stitching 360. The molded cover 220 is, in turn, attachedto the electrode 107.

[0390] The molded cover 220 comprises an outer surface 1330 and a topsurface 1331. The outer surface 1330 of the molded cover 220 is thesurface of the molded cover 220 that does not lie adjacent to thebacking layer 131 or the electrode 107. The top surface 1331 of themolded cover 220 faces away from, and parallel to the electrode 107.

[0391] The layer of material 1315 of the pocket 1300 comprises an innerface 1316 and an outer face 1317. The layer of material 1315 is attachedto the top surface 1331 of the molded cover 220 so that the inner face1316 of the layer of material 1315 faces the top surface 1331 of themolded cover 220. The inner face 1316 of the layer of material 1315 alsofaces the top surface 110 of the electrode 107.

[0392] The layer of material 1315 is made of polyurethane. In otherembodiments, the layer of material 1315 is made of any bio-compatiblematerial suitable for this purpose. In other embodiments, the layer ofmaterial 1315 is made of any bio compatible polymeric material.

[0393] The stitching 360 fastening the layer of material 1315 to the topsurface 1331 of the molded cover 220 is comprised of nylon. In alternateembodiments, the stitching 360 comprises any polymeric material.

[0394]FIG. 36(b) illustrates a top plan view of the lead electrodeassembly 100 of FIG. 36(a). The top surface 1331 of the molded cover 220has a first side 1333, a second side 1334, a distal end 1336, a proximalend 1337, a length and a width.

[0395] The distal end 1336, proximal end 1337, first side 1333 andsecond side 1334 of the top surface 1331 of the molded cover 220 arepositioned substantially over the distal end 137 (phantom view),proximal end 138 (phantom view), first side 133 (not shown) and secondside 134 (not shown) of the backing layer 130 (phantom view)respectively.

[0396] The width of the top surface 1331 of the molded cover 220 ismeasured as the distance between the first side 1333 and second side1334 of the back surface. The length of the top surface 1331 of themolded cover is measured as the distance between the distal end 1336 andproximal end 1337 of the molded cover 220.

[0397] The layer of material 1315 comprises a periphery 1318 and amiddle portion 1319. More particularly, the layer of material 1315comprises a distal end 1320, a proximal end 1321, a first side 1322 anda second side 1323. The periphery 1318 of the layer of material 1315comprises the distal end 1320, the proximal end 1321, the first side1322 and the second side 1323 of the layer of material 1315. The middleportion 1319 of the layer of material 1315 comprises the area betweenthe distal end 1320, the proximal end 1321, the first side 1322 and thesecond side 1323 of the layer of material 1315.

[0398] The pocket 1300 formed by the layer of material 1315 furthercomprises a bounded region 1325 and a center 1326. The bounded region1325 of the pocket 1300 is attached to the back face 1317 of the moldedcover 220. The center 1326 of the pocket 1300 is not attached to theback face 1317 of the molded cover 220. Stitching 360 in the boundedregion 1325 is used to attach the layer of material 1315 to the moldedcover 220.

[0399] In the embodiment under discussion, the bounded region 1325 ofthe pocket 1300 comprises a portion of the periphery 1318 of the layerof material 1315. The bounded region 1325 of the pocket 1300 comprisesthe proximal end 1321, the first side 1322 and the second side 1323 ofthe layer of material 1315. In this embodiment, the bounded region 1325of the pocket 1300 does not comprise the distal end 1320 of the layer ofmaterial 1315. The center 1326 of the pocket 1300 comprises the middleportion 1319 of the layer of material 1315. The bounded region 1325 iscurved around the center 1326 of the pocket 1300 in a “U” shape. Thebounded region 1325 of the pocket 1300 does not completely enclose thecenter 1326 of the pocket 1300.

[0400] In this embodiment, the bounded region 1325 of the pocketcomprises a contiguous portion of the periphery 1318 of the layer ofmaterial 1315. In an alternate embodiment, the bounded region 1325 ofthe pocket comprises a plurality of segmented portions of the periphery1318 of the layer of material 1315.

[0401] In an alternate embodiment the bounded region 1325 of the pocket1300 does not comprise any portion of the periphery 1318 of the layer ofmaterial 1315. In alternate embodiments, the bounded region 1325comprises any shape that could be traced on the layer of material 1315that partially encloses a center 1326. In one embodiment, the boundedregion 1325 of the pocket 1300 is a portion of a circle's circumference(not shown) that does not touch the periphery 1318 of the layer ofmaterial 1315. The center 1326 is the area inside the circle.

[0402] In an alternate embodiment, the pocket 1300 comprises a sheet ofmolded silicone. The molded silicone is fused to the molded cover 220 inthe bounded region 1325.

[0403] The opening 1310 of the pocket 1300 comprises the area betweenthe distal end 1320 of the layer of material 1315 and the top surface1331 of the molded cover 220. The interior 1305 of the pocket 1300comprises the area between the middle portion 1319 of the layer ofmaterial 1315 and the top surface 1331 of the molded cover 220.

[0404] The layer of material 1315 is positioned so that its first side1322 and second side 1323 are positioned over the first side 1333 andsecond side 1334 of the top surface 1331 of the molded cover 220respectively. The layer of material 1315 is positioned so that itsproximal end 1321 is positioned over the proximal end 1337 of the topsurface 1331 of the molded cover 220.

[0405] The layer of material 1315 is sized so that its length is shorterthan the length of the top surface 1331 of the molded cover 220. Inalternate embodiments, the layer of material 1315 is sized so that itslength is equal to, or longer than the length of the top surface 1331 ofthe molded cover 220.

[0406] The proximal end 1321 of the layer of material 1315 is sized sothat its width is substantially equal to the width of the proximal end1337 of the top surface 1331 of the molded cover 220. The layer ofmaterial 1315 is sized so that its width steadily increases toward itsdistal end 1320.

[0407] The first side 1318 of the distal end 1320 of the layer ofmaterial 1315 is fastened to the first side 1333 of the top surface 1331of the molded cover 220. The second side 1323 of the distal end 1320 ofthe layer of material 1315 is fastened to the second side 1334 of thetop surface 1331 of the molded cover 220.

[0408] Since the first end 1322 of the layer of material 1315 is widerthan the top surface 1331 of the molded cover 220, the layer of material1315 separates from the top surface 1331 of the molded cover 220 to formthe interior 1305 of the pocket 1300.

[0409] In an alternate embodiment, the lead electrode assembly 100 lacksa molded cover 220 and the pocket 1300 is attached directly to thebacking layer 130. In another alternate embodiment the lead electrodeassembly 100 lacks a molded cover 220 and a backing layer 130 and thepocket 1300 is attached directly to the electrode 107. In a furtheralternate embodiment, the pocket 1300 is molded as part of the moldedcover 220.

[0410]FIG. 36(c) illustrates a cross-sectional side plan view of analternative embodiment of the lead electrode assembly 100.

[0411] This embodiment is substantially similar to the embodimentillustrated in FIGS. 36(a)-36(b). The backing layer 130 of thisembodiment, however, further comprises a fin 120 positioned in theinterior 1305 of the pocket 1300. The fin 120 of this embodiment issubstantially similar to the fin 120 of the embodiment illustrated inFIG. 17(b).

[0412] The fin 120 comprises an integrated fin tab 180 formed on thebacking layer 130. The molded cover 220 covers the integrated fin tab180 to form the fin 120. The integrated fin tab 180 has a slope-shapedproximal edge 183. The sloped-shape of the resulting fin 120 permits athe fin 120 to fit deeply into the interior 1305 of the pocket 1300. Thehood can act to reduce the resistance presented by the tissues of thepatient against the fin 120 and any tool used to grasp the fin 120during insertion of the lead electrode assembly 100. Such a hood can beplaced over any fin discussed in the specification to perform thisfunction or any other function.

[0413] In alternate embodiments, appendages other than a fin arepositioned between the pocket 1300 and the electrode 107, in theinterior 1305 of the pocket 1300. In one embodiment, a loop such as thatdiscussed with reference to FIGS. 21(a)-21(c) is positioned in theinterior 1305 of the pocket 1300. In another embodiment, a tube such asthat discussed with reference to FIG. 26 is positioned in the interior1305 of the pocket 1300.

[0414]FIG. 37(a) and 37(b) illustrates an alternate embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiment illustrated in FIGS. 36(a)-36(b).

[0415]FIG. 37(a) illustrates a bottom plan view of the lead electrodeassembly 100 of this embodiment. In this embodiment, the electrode 107is thumbnail shaped.

[0416]FIG. 37(b) illustrates a top plan view of the lead electrodeassembly 100 of this embodiment. The top surface 1331 of the moldedcover 220 is shaped to accommodate the thumbnail shaped electrode 107.

[0417] Like the embodiment discussed with reference to FIGS. 36(a) and36(b), the pocket 1300 comprises a layer of material 1315.

[0418] In this embodiment, however, the layer of material 1315 has aroughly triangular shape. The layer of material 1315 comprises aperiphery 1318 and a middle portion 1319. More particularly, the layerof material comprises a first side 1340, a second side 1341 and a thirdside 1342 of the layer of material 1315. The periphery 1318 of the layerof material comprises the first side 1340, the second side 1341 and thethird side 1342 of the layer of material 1315. The middle portion 1319of the layer of material 1315 comprises the area between the first side1340, the second side 1341 and the third side 1342 of the layer ofmaterial 1315.

[0419] In this embodiment, the bounded region 1325 of the pocket 1300comprises a portion of the periphery 1318 of the layer of material 1315.The bounded region 1325 of the pocket 1300 comprises the first side 1340and the second side 1341 of the layer of material 1315. The center 1326of the pocket 1300 comprises the middle portion 1319 of the layer ofmaterial 1315. The opening 1310 of the pocket 1300 comprises the thirdside 1342 of the layer of material 1315 and the top surface 1331 of themolded cover 220. The bounded region 1325 of the pocket 1300 is curvedaround the center 1326 of the pocket 1300. The bounded region 1325 ofthe pocket 1300 does not completely enclose the center 1326.

[0420] In this embodiment, the bounded region 1325 of the pocketcomprises a contiguous portion of the periphery 1318 of the layer ofmaterial 1315. In an alternate embodiment, the bounded region 1325 ofthe pocket comprises a plurality of segmented portions of the periphery1318 of the layer of material 1315.

[0421] In an alternate embodiment the bounded region 1325 of the pocket1300 does not comprise any portion of the periphery 1318 of the layer ofmaterial 1315.

[0422]FIG. 38(a)-38(c) illustrates a lead electrode assemblymanipulation tool 927. The lead electrode assembly manipulation tool 927illustrated is useful for manipulating a lead electrode assembly 100having a pocket 1300 during the implantation of the lead electrodeassembly 100 in a patient. Examples of such a lead electrode assembly100 embodiments are shown in FIGS. 36(a), 36(b), 37(a) and 37(b).

[0423]FIG. 38(a) is a top view of the lead electrode assemblymanipulation tool 927 of this embodiment. The lead electrode assemblymanipulation tool 927 comprises a handle 1142 (not shown), a rod 1144and a paddle 1350.

[0424] The rod 1144 and handle 1142 are substantially similar to the rod1144 and handle 1142 of the lead electrode assembly manipulation tool927 illustrated in FIGS. 35(a)-35(d). The handle 1142 is connected tothe rod 1144.

[0425] The paddle 1350 is attached to the distal end 1148 of the rod1144. The paddle 1350 comprises a disk 1351 and a tang 1161 (phantomview).

[0426]FIG. 38 (b) is a side view of the lead electrode assemblymanipulation tool 927 of this embodiment. The tang 1161 is inserted inthe slot 1162 in the rod 1144. The tang 1161 is welded into the slot1162 of the rod 1144.

[0427] The disk 1351 and the tang 1161 are punched from a single sheetof steel having a thickness of approximately 3 mm. In other embodiments,the disk 1351 and tang 1161 are composed of titanium, a polymericmaterial or any other material suitable for this purpose. In oneembodiment, the handle 1142, the rod 1144 and the paddle 1350 are allmade from the same piece of material.

[0428] We now turn to FIG. 38(c) for a description of the use of thelead electrode assembly manipulation tool 927 in the implantation of alead electrode assembly 100 into a patient.

[0429] As discussed with reference to FIG. 31, an incision 905 is madein the patient 900. As discussed with reference to FIG. 32(a), asubcutaneous path 1090 is created in the patient 900 with a hemostat932.

[0430] The lead electrode assembly 100 is then captured by the leadelectrode assembly manipulation tool 927. The paddle 1350 of the leadelectrode assembly manipulation tool 927 is inserted into the pocket1300 of the lead electrode assembly 100. The paddle 1350 is slid intothe interior 1305 of the pocket via the opening 1310 of the pocket untilit can go no further. At this point, the paddle 1350 touches the innersurface 1316 of the proximal end 1321 of the layer of material 1315.

[0431] The lead 21 of the lead electrode assembly 100 can then be pulledtoward the handle 1142 of the lead electrode assembly manipulation tool927 until it is taught. This acts to prevent the paddle 1350 of the leadelectrode assembly manipulation tool 927 from sliding out of the pocket1300 of the lead electrode assembly 100.

[0432] The lead electrode assembly manipulation tool 927 may then beused to place the lead electrode assembly 100 into the incision 905 ofthe patient as seen in FIG. 31. The lead electrode assembly manipulationtool 927 may then be used to move the electrode 107 to the terminationpoint 1085 of the subcutaneous path 1090 created as discussed withreference to FIG. 32(c).

[0433] The lead electrode assembly 100 is then released from the leadelectrode assembly manipulation tool 927. To achieve this, the lead 21of the lead electrode assembly 100 is released so that the paddle 1350can slide relative to the pocket 1300 of the lead electrode assembly100. The lead electrode assembly manipulation tool 927 may then beextracted from the subcutaneous path 1090 leaving the lead electrodeassembly 100 behind.

[0434] Alternately, a curved hemostat, such as the hemostat 930discussed with reference to FIG. 32(b) could be inserted in the pocket1300 of the lead electrode assembly 100. The hemostat could then be usedto move the electrode 107 to the termination point 1085 of thesubcutaneous path 1090 as discussed above.

[0435] Alternately, a curved hemostat, such as the hemostat 930discussed with reference to FIG. 32(b) could be used to grip the thepocket 1300 of the lead electrode assembly 100, and used to move theelectrode 107 to the termination point 1085 of the subcutaneous path1090 as discussed above.

[0436] FIGS. 39(a)-39(b) illustrate an alternative embodiment of thelead electrode assembly 100. This embodiment is substantially similar tothe embodiment illustrated in FIGS. 38(a)-38(c). The backing layer 130of this embodiment, however, lacks a pocket 1300. Moreover, the leadelectrode assembly 100 of this embodiment further comprises a firstchannel guide 1401 and a second channel guide 1402.

[0437]FIG. 39(a) illustrates a cross-sectional rear plan view of thelead electrode assembly 100 of this embodiment. The first channel guide1401 and a second channel guide 1402 each have an interior 1403 and anopening 1404.

[0438] The first channel guide 1401 and the second channel guide 1402each comprise a strip of material 1406 attached to the molded cover 220.

[0439] The strip of material 1406 comprising the first channel guide1401 is substantially rectangular in shape. The strip of material 1406comprises a first side 1410 and a second side 1412. The first side 1410and the second side 1412 of the strip of material 1406 are parallel toeach other. In another embodiment, the first side 1410 of the strip ofmaterial 1406 is not parallel to the second side 1412.

[0440] The strip of material 1406 further comprises an inner surface1417 and a outer surface 1416. The strip of material is positioned sothat the inner surface 1417 of the first side 1410 faces the outersurface 1330 of the molded cover 220. The first side 1410 of the stripof material is attached to the first side 1333 of the top surface 1331of the molded cover 220. The second side 1412 of the strip of material1406 is attached to the skirt 222 of the molded cover 220.

[0441] The interior 1403 of the first channel guide is formed betweenthe inner face 1417 of the strip of material 1406 and the outer surface1330 of the molded cover 220.

[0442] The second channel guide is formed in substantially the same wayon the second side 1334 of the molded cover 220.

[0443]FIG. 39(b) illustrates a top plan view of the lead electrodeassembly of the embodiment of FIG. 39 (a). The strip of material 1406comprising the first channel guide 1401 is substantially rectangular inshape having a distal end 1413 and a proximal end 1414. The distal end1413 and the proximal end 1414 of the strip of material 1406 areparallel to each other. In another embodiment, the distal end 1413 ofthe strip of material 1406 is not parallel to the proximal end 1414 ofthe strip of material 1406.

[0444] The opening 1404 of the first channel guide 1401 is formed by thedistal end 1413 of the strip of material 1406 and the outer surface 1330of the molded cover 220.

[0445] The first side 1410 and the second side 1412 (not shown) of thestrip of material 1406 comprising the first channel guide 1401 arepositioned so that they lie parallel to the first side 1333 (phantomview) of the molded cover 220.

[0446] The second channel guide 1402 is formed and mounted to the leadelectrode assembly 100 in substantially the same way as the firstchannel guide 1401. The first side 1410 and the second side 1412 (notshown) of the strip of material 1406 comprising the second channel guide1402 are positioned so that they lie parallel to the second side 1333(phantom view) of the molded cover 220.

[0447] The strips of material 1406 are composed of polyurethane. In analternate embodiment, the strips of material 1406 are composed of anypolymeric material. The strips of material 1406 are fastened to themolded cover 220 with stitching 360.

[0448] In an alternate embodiment, the strips of material 1406 are madeof molded silicone and attached to the molded cover 220 by fusing themto the molded cover 220. In an alternate embodiment, the first channelguide 1401 and the second channel guide 1402 are formed as part of themolded cover 220.

[0449]FIG. 40(a)-40(b) illustrates a lead electrode assemblymanipulation tool 927. The lead electrode assembly manipulation tool 927illustrated is useful for manipulating a lead electrode assembly 100having a first channel guide 1401 and a second channel guide 1402 duringthe implantation of the lead electrode assembly 100 in a patient.Examples of such a lead electrode assembly 100 embodiments are shown inFIGS. 39(a)-39(b).

[0450]FIG. 40(a) illustrates a top plan view of a lead electrodeassembly manipulation tool 927. The lead electrode assembly manipulationtool 927 in this embodiment comprises a handle 1142 (not shown), a rod1144 and a channel guide fork 1446.

[0451] The rod 1144 and handle 1142 are substantially similar to the rod1144 and handle 1142 of the lead electrode assembly manipulation tool927 illustrated in FIGS. 35(a)-35(d). The handle 1142 is connected tothe rod 1144.

[0452] The channel guide fork 1446 is attached to the distal end 1148 ofthe rod 1144. The channel guide fork 1446 comprises a pair of tines 1451separated by a gap 1455 and a tine base 1450 having a tang 1161.

[0453] The pair of tines 1451 each have a proximal end 1452 and a distalend 1453. The proximal ends 1452 of the pair of tines 1451 are attachedto the tine base 1450. The pair of tines 1451 have a substantiallycylindrical form. The distal end 1453 of each of the pair of tines 1451is rounded.

[0454] The length of the pair of tines 1451 is substantially equal tothe length of the first side 1410 of the strips of material 1406comprising the first channel guide 1401 and second channel guide 1402.In alternate embodiments, the length of the tines 1451 is substantiallygreater than or less than the length of the first side 1410 of thestrips of material 1406 comprising the first channel guide 1401 andsecond channel guide 1402.

[0455] The tines are separated by a gap 1455 between the proximal ends1452 of the pair of tines 1451. The pair of tines 1451 are substantiallystraight and substantially parallel to each other.

[0456] The tine base 1450 connects the pair of tines 1451 to the distalend 1148 of the rod 1144. The tine base 1450 comprises a tang 1161(phantom view). The tang 1161 is inserted in a slot 1162 in the rod1144. The tang 1161 is welded in the slot 1162 of the rod 1144.

[0457] The pair of tines 1451 comprising the channel guide fork 1446 arecomposed of steel and have a diameter of approximately 3 mm. The tinebase 1450 comprising the channel guide fork 1446 is punched from asingle strip of steel having a thickness of approximately 3 mm. The pairof tines 1451 are welded to the tine base 1450.

[0458] In other embodiments, the channel guide fork 1446 is composed ofmetal, a polymeric material, or any other material suitable for thispurpose. In one embodiment, the handle 1142, the rod 1144 and thechannel guide fork 1446 are all made from the same piece of material.

[0459] We now turn to FIG. 40(b) for a description of the use of thelead electrode assembly manipulation tool 927 in the implantation of alead electrode assembly 100 into a patient.

[0460] As discussed with reference to FIG. 31, an incision 905 is madein the patient 900. As discussed with reference to FIG. 32(a), asubcutaneous path 1090 is created in the patent 900 with a hemostat 932.

[0461] The lead electrode assembly 100 is then captured by the leadelectrode assembly manipulation tool 927. The pair of tines 1451 of thelead electrode assembly manipulation tool 927 is inserted into theopenings 1404 in the first channel guide 1401 and second channel guide1402.

[0462] The electrode 107 is placed into the gap 1455 between the tinesof the channel guide fork 1446. The tines 1451 fit into the interior1403 of the first channel guide 1401 and second channel guide 1402. Themolded cover is slid toward the proximal end 1452 of the tines until itcan go no further. The lead 21 of the lead electrode assembly 100 canthen be pulled in toward the handle 1142 of the lead electrode assemblymanipulation tool 927 until it is taught. This acts to prevent the leadelectrode assembly 100 from sliding toward the distal end 1453 of thepair of tines 1451 of the channel guide fork 1446.

[0463] The lead electrode assembly manipulation tool 927 may then beused to place the lead electrode assembly 100 into the incision 905 ofthe patient as seen in FIG. 31. The lead electrode assembly manipulationtool 927 may then be used to move the electrode 107 through thetermination point 1085 of the subcutaneous path 1090 created asdiscussed with reference to FIG. 32(c).

[0464] The lead electrode assembly 100 is then released from the leadelectrode assembly manipulation tool 927. To achieve this, the lead 21of the lead electrode assembly 100 is released so that the pair of tines1451 of the channel guide fork 1446 of the lead electrode assemblymanipulation tool 927 can slide relative to the first channel guide 1401and second channel guide 1402 of the lead electrode assembly 100. Thelead electrode assembly manipulation tool 927 may then be extracted fromthe subcutaneous path 1090 leaving the lead electrode assembly 100behind.

[0465]FIG. 41(a) illustrates a subcutaneous implantablecardioverter-defibrillator kit 1201 of the present invention. The kitcomprises a group of items that may be used in implanting a S-ICD systemin a patient. The kit 1201 comprises a group of one or more of thefollowing items: an S-ICD canister 11, a lead electrode assembly 100, ahemostat 1205, a lead electrode assembly manipulation tool 927, amedical adhesive 1210, an anesthetic 1215, a tube of mineral oil 1220and a tray 1200 for storing these items.

[0466] In one embodiment, the S-ICD canister 11 is the S-ICD canister 11seen in, and discussed with reference to FIG. 1.

[0467] The lead electrode assembly 100 is the lead electrode assembly100 with a rail 1100, and discussed with reference to FIGS. 33(b) and33(c). In alternate embodiments, the lead electrode assembly 100 is anylead electrode assembly 100 including an electrode 107 with an appendage118; a pocket; or a first and second channel guide for positioning theelectrode 107 during implantation.

[0468] The hemostat 1205 is a curved hemostat made of steel having afirst end 1240 and a second end 1241. The hemostat 1205 has a length,measured between the first end 1240 and the second end 1241 as shown inFIG. 41(b) by dimension L_(Hemostat). The length of the hemostat 1205,L_(Hemostat), is approximately 75 cm. In an alternate embodiments, thehemostat 1205 is a length other than 75 cm. In an alternate embodiment,the hemostat 1205 is the enhanced hemostat seen in, and discussed withreference to FIG. 31.

[0469] The lead electrode assembly manipulation tool 927 is the leadelectrode assembly manipulation tool 927 with a rail fork 1146. Inalternate embodiments, the lead electrode assembly manipulation tool 927is any lead electrode assembly manipulation tool 927 including a paddleor a channel guide fork.

[0470] The medical adhesive 1210 comprises a roll of clear, 1-inch widemedical adhesive tape. As will be recognized, the medical adhesive couldbe a liquid adhesive, or any other adhesive substance.

[0471] The anesthetic 1215 is a one ounce tube of lidocaine gel. Thiscan be used as a local anesthetic for the introduction of the leadelectrode assembly 100 as discussed below. As will be recognized, theanesthetic could be any substance that has a pain-killing effect.Alternatively, one could use an injectable form of anesthetic insertedalong the path of the lead.

[0472] The tube of mineral oil 1220 is a one ounce tube of mineral oil.This can be used for oiling parts of the electrode connector block 17seen in FIG. 1.

[0473] The tray 1200 is a box sized to fit the items of the kit 1201.The tray 1200 is composed of molded plastic. In another embodiment, thetray 1200 is a cardboard box. One skilled in the art will recognize thatthe tray 1200 may comprise any container capable of containing the itemsof the kit. In one embodiment, the tray is formed with recessedpartitions 1230 that generally follow the outline of the items of thekit 1201 to be stored in the tray. In one embodiment, the tray 1200 haspackaging material 1225 disposed over it, wherein the packing material1225 provides a sanitary cover for the items of the kit 1201. Thepackaging material 1225 further acts to contain the items of the kit1201.

[0474] In an alternate embodiment the kit 1201 comprises ten leadelectrode assemblies 100 each comprising a lead 21 having a lead length,l_(Lead), different from the others. In one embodiment, the lead lengthsrange between approximately 5 cm and approximately 52 cm withapproximately a 10 cm difference between the lead length of each leadelectrode assembly 100.

[0475] In an alternative embodiment, the kit 1201 comprises an SICDcanister 11, a hemostat 1205 and an assortment of lead electrodeassemblies 100 each comprising a lead 21 having a lead length, l_(Lead),different from the others.

[0476] In one embodiment, the kit 1200 further comprises a tray 1201 andan assortment of lead electrode assemblies 100, each with an electrode107 curved at a radius r different from the others.

[0477] In another embodiment, the kit 1200 includes components sized forsurgery on a patient of a particular size. A kit 1200 for a 10 year oldchild, for example, includes an S-ICD canister 11 with a length ofapproximately 10 cm, a lead electrode assembly 100 with a lead length,L_(Lead) of approximately 12 cm and a radius r of approximately 10 cmand hemostat 1205 with a hemostat length, L_(Hemostat), of approximately12 cm.

[0478] The S-ICD device and method of the present invention may beembodied in other specific forms without departing from the teachings oressential characteristics of the invention. The described embodimentsare therefore to be considered in all respects as illustrative and notrestrictive, the scope of the invention being indicated by the appendedclaims rather than by the foregoing description and all changes whichcome within the meaning and range of equivalency of the claims aretherefore to be embraced therein.

What is claimed is:
 1. A lead electrode assembly for use with animplantable cardioverter-defibrillator subcutaneously implanted outsidea patient's ribcage between the third and twelfth ribs, wherein the leadelectrode assembly comprises an electrode.
 2. The lead electrodeassembly of claim 1, wherein the electrode can emit an effective energyfor shocking the patient's heart.
 3. The lead electrode assembly ofclaim 2, wherein the effective energy for shocking the patient's heartis approximately 25 J to approximately 50 J.
 4. The lead electrodeassembly of claim 2, wherein the effective energy for shocking thepatient's heart is approximately 50 J to approximately 75 J.
 5. The leadelectrode assembly of claim 2, wherein the effective energy for shockingthe patient's heart is approximately 75 J to approximately 100 J.
 6. Thelead electrode assembly of claim 2, wherein the effective energy forshocking the patient's heart is approximately 100 J to approximately 125J.
 7. The lead electrode assembly of claim 2, wherein the effectiveenergy for shocking the patient's heart is approximately 125 J toapproximately 150 J.
 8. The lead electrode assembly of claim 2, whereinthe effective energy for shocking the patient's heart is approximately150 J.
 9. The lead electrode assembly of claim 2, wherein the electrodecan further receive physiological information from the patient throughsensors.
 10. The lead electrode assembly of claim 1, wherein theelectrode can receive physiological information from the patient throughsensors.
 11. The lead electrode assembly of claim 1, wherein at least aportion of the electrode is non-planar.
 12. The lead electrode assemblyof claim 1, wherein the electrode is substantially ellipsoidal in shape.13. The lead electrode assembly of claim 1, wherein the electrode issubstantially thumbnail shaped.
 14. The lead electrode assembly of claim1, wherein the electrode is substantially circular in shape.
 15. Thelead electrode assembly of claim 1, wherein the electrode issubstantially square in shape.
 16. The lead electrode assembly of claim15, wherein the electrode comprises rounded corners.
 17. The leadelectrode assembly of claim 1, wherein the electrode is substantiallyrectangular in shape.
 18. The lead electrode assembly of claim 17,wherein the electrode comprises rounded corners.
 19. The lead electrodeassembly of claim 1, wherein the electrode is substantially triangularin shape.
 20. The lead electrode assembly of claim 19, wherein theelectrode comprises rounded corners.
 21. The lead electrode assembly ofclaim 1, wherein the electrode is less than approximately 1000 squaremillimeters in area.
 22. The lead electrode assembly of claim 21,wherein the electrode is between approximately 750 square millimeters toapproximately 1000 square millimeters in area.
 23. The lead electrodeassembly of claim 22, wherein the electrode is between approximately 500square millimeters to approximately 750 square millimeters in area. 24.The lead electrode assembly of claim 1, wherein the electrode is betweenapproximately 250 square millimeters to approximately 500 squaremillimeters in area.
 25. The lead electrode assembly of claim 1, whereinthe electrode is between approximately 100 square millimeters toapproximately 250 square millimeters in area.
 26. The lead electrodeassembly of claim 1, wherein the electrode is positioned approximatelyin a posterior region of the patient's ribcage.
 27. The lead electrodeassembly of claim 1, wherein the electrode is positioned approximatelyin a paraspinal region of the patient.
 28. The lead electrode assemblyof claim 1, wherein the electrode is positioned approximately in aparascapular region of the patient.
 29. The lead electrode assembly ofclaim 1, wherein the electrode is positioned approximately posterior toa mid axillary line of the patient.
 30. The lead electrode assembly ofclaim 1, wherein the electrode is positioned approximately posterior andlateral to an anterior axillary line of the patient.
 31. The leadelectrode assembly of claim 1, wherein lead electrode assembly furthercomprises a backing layer coupled to the electrode.
 32. The leadelectrode assembly of claim 31, wherein the backing layer comprises apolymeric material.
 33. The lead electrode assembly of claim 32, whereinthe polymeric material is selected from the group consisting essentiallyof a polyurethane, a polyamide, a polyetheretherketone (PEEK), apolyether block amide (PEBA), a polytetrafluoroethylene (PTFE), asilicone, and mixtures thereof.
 34. The lead electrode assembly of claim31, wherein the backing layer is substantially planar.
 35. The leadelectrode assembly of claim 34, wherein the backing layer issubstantially parallel to the electrode.
 36. The lead electrode assemblyof claim 1, wherein at least a portion of the electrode is covered by askirt.
 37. The lead electrode assembly of claim 1, wherein the leadelectrode assembly further comprises a molded cover coupled to theelectrode.
 38. The lead electrode assembly of claim 37, wherein themolded cover partially covers the electrode
 39. The lead electrodeassembly of claim 38, wherein the molded cover comprises a skirt thatpartially covers a bottom surface of the electrode.
 40. The leadelectrode assembly of claim 37, wherein the molded cover comprises apolymeric material.
 41. The lead electrode assembly of claim 40, whereinthe polymeric material is selected from the group consisting essentiallyof a polyurethane, a polyamide, a polyetheretherketone (PEEK), apolyether block amide (PEBA), a polytetrafluoroethylene (PTFE), asilicone, and mixtures thereof.
 42. The lead electrode assembly of claim1, wherein the electrode comprises a mesh of metallic material.
 43. Thelead electrode assembly of claim 42, wherein the metallic material isselected from the group consisting essentially of titanium, nickelalloys, stainless steel alloys, platinum, platinum iridium, and mixturesthereof.
 44. The lead electrode assembly of claim 1, wherein theelectrode comprises a metallic material.
 45. The lead electrode assemblyof claim 44, wherein the metallic material is selected from the groupconsisting essentially of titanium, nickel alloys, stainless steelalloys, platinum, platinum iridium, and mixtures thereof.
 46. The leadelectrode assembly of claim 1, wherein the electrode is substantiallyplanar.
 47. The lead electrode assembly of claim 1, wherein theelectrode comprises a substantially flat sheet of metallic material. 48.The lead electrode assembly of claim 47, wherein the metallic materialis selected from the group consisting essentially of titanium, nickelalloys, stainless steel alloys, platinum, platinum iridium, and mixturesthereof.
 49. The lead electrode assembly of claim 1, wherein the leadelectrode assembly further comprises a lead coupled to the electrode.50. The lead electrode assembly of claim 49, wherein the lead comprisesone or more electrical conductors electrically coupled to the electrode.51. The lead electrode assembly of claim 50, wherein the lead furthercomprises an electrically insulating sheath enclosing the one or moreelectrical conductors.
 52. The lead electrode assembly of claim 49,wherein the lead electrode assembly further comprises a connectorcoupled to the lead.
 53. The lead electrode assembly of claim 52,wherein the connector is electrically coupled to the electrode.
 54. Thelead electrode assembly of claim 49, wherein the lead is betweenapproximately 5 cm and approximately 52 cm in length.
 55. The lea delectrode assembly of claim 54, wherein the lead is betweenapproximately 5 cm and approximately 30 cm in length.
 56. The leadelectrode assembly of claim 55, wherein the lead is betweenapproximately 10 cm and approximately 20 cm in length.
 57. The leadelectrode assembly of claim 54, wherein the lead length is one of aplurality of pre-set lengths.
 58. The lead electrode assembly of claim57, wherein the pre-set lengths vary by approximately 10 cm.
 59. Thelead electrode assembly of claim 49, wherein the lead has a proximal endand a distal end and wherein the proximal end of the lead is coupled tothe electrode.
 60. The lead electrode assembly of claim 59, wherein thelead electrode assembly further comprises a lead fastener coupledbetween the lead and the electrode.
 61. An implantablecardioverter-defibrillator for subcutaneous positioning between thethird rib and the twelfth rib within a patient, the implantablecardioverter-defibrillator comprising: a housing; an electrical circuitlocated within the housing; a first electrode coupled to the electricalcircuit and located on the housing; and a lead electrode assemblycoupled to the housing, wherein the lead electrode assembly comprises: asecond electrode coupled to the electrical circuit.
 62. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode canemit an effective energy for shocking the patient's heart.
 63. Theimplantable cardioverter-defibrillator of claim 62, wherein theeffective energy for shocking the patient's heart is approximately 25 Jto approximately 50 J.
 64. The implantable cardioverter-defibrillator ofclaim 62, wherein the effective energy for shocking the patient's heartis approximately 50 J to approximately 75 J.
 65. The implantablecardioverter-defibrillator of claim 62, wherein the effective energy forshocking the patient's heart is approximately 75 J to approximately 100J.
 66. The implantable cardioverter-defibrillator of claim 62, whereinthe effective energy for shocking the patient's heart is approximately100 J to approximately 125 J.
 67. The implantablecardioverter-defibrillator of claim 62, wherein the effective energy forshocking the patient's heart is approximately 125 J to approximately 150J.
 68. The implantable cardioverter-defibrillator of claim 62, whereinthe effective energy for shocking the patient's heart is approximately150 J.
 69. The implantable cardioverter-defibrillator of claim 62,wherein the second electrode can further receive physiologicalinformation from the patient through sensors.
 70. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode canreceive physiological information from the patient through sensors. 71.The implantable cardioverter-defibrillator of claim 61, wherein at leasta portion of the second electrode is non-planar.
 72. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode issubstantially ellipsoidal in shape.
 73. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode issubstantially thumbnail shaped.
 74. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode issubstantially circular in shape.
 75. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode issubstantially square in shape.
 76. The implantablecardioverter-defibrillator of claim 75, wherein the second electrodecomprises rounded corners.
 77. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode issubstantially rectangular in shape.
 78. The implantablecardioverter-defibrillator of claim 77, wherein the second electrodecomprises rounded corners.
 79. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode issubstantially triangular in shape.
 80. The implantablecardioverter-defibrillator of claim 79, wherein the second electrodecomprises rounded corners.
 81. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode isless than approximately 1000 square millimeters in area.
 82. Theimplantable cardioverter-defibrillator of claim 81, wherein the secondelectrode is between approximately 750 square millimeters toapproximately 1000 square millimeters in area.
 83. The implantablecardioverter-defibrillator of claim 82, wherein the second electrode isbetween approximately 500 square millimeters to approximately 750 squaremillimeters in area.
 84. The implantable cardioverter-defibrillator ofclaim 61, wherein the second electrode is between approximately 250square millimeters to approximately 500 square millimeters in area. 85.The implantable cardioverter-defibrillator of claim 61, wherein thesecond electrode is between approximately 100 square millimeters toapproximately 250 square millimeters in area.
 86. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode ispositioned approximately in a posterior region of the patient's ribcage.87. The implantable cardioverter-defibrillator of claim 61, wherein thesecond electrode is positioned approximately in a paraspinal region ofthe patient.
 88. The implantable cardioverter-defibrillator of claim 61,wherein the second electrode is positioned approximately in aparascapular region of the patient.
 89. The implantablecardioverter-defibrillator of claim 61, wherein the second electrode ispositioned approximately posterior to a mid axillary line of thepatient.
 90. The implantable cardioverter-defibrillator of claim 61,wherein the second electrode is positioned approximately posterior andlateral to an anterior axillary line of the patient.
 91. The implantablecardioverter-defibrillator of claim 61, wherein lead electrode assemblyfurther comprises a backing layer coupled to the second electrode. 92.The implantable cardioverter-defibrillator of claim 91, wherein thebacking layer comprises a polymeric material.
 93. The implantablecardioverter-defibrillator of claim 92, wherein the polymeric materialis selected from the group consisting essentially of a polyurethane, apolyamide, a polyetheretherketone (PEEK), a polyether block amide(PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixturesthereof.
 94. The implantable cardioverter-defibrillator of claim 92,wherein the backing layer is substantially planar.
 95. The implantablecardioverter-defibrillator of claim 94, wherein the backing layer issubstantially parallel to the second electrode.
 96. The implantablecardioverter-defibrillator of claim 61, wherein at least a portion ofthe second electrode is covered by a skirt.
 97. The implantablecardioverter-defibrillator of claim 61, wherein the lead electrodeassembly further comprises a molded cover coupled to the secondelectrode.
 98. The implantable cardioverter-defibrillator of claim 97,wherein the molded cover partially covers the second electrode
 99. Theimplantable cardioverter-defibrillator of claim 98, wherein the moldedcover comprises a skirt that partially covers a bottom surface of thesecond electrode.
 100. The implantable cardioverter-defibrillator ofclaim 97, wherein the molded cover comprises a polymeric material. 101.The implantable cardioverter-defibrillator of claim 100, wherein thepolymeric material is selected from the group consisting essentially ofa polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyetherblock amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, andmixtures thereof.
 102. The implantable cardioverter-defibrillator ofclaim 61, wherein the second electrode comprises a mesh of metallicmaterial.
 103. The implantable cardioverter-defibrillator of claim 102,wherein the metallic material is selected from the group consistingessentially of titanium, nickel alloys, stainless steel alloys,platinum, platinum iridium, and mixtures thereof.
 104. The implantablecardioverter-defibrillator of claim 61, wherein the second electrodecomprises a metallic material.
 105. The implantablecardioverter-defibrillator of claim 104, wherein the metallic materialis selected from the group consisting essentially of titanium, nickelalloys, stainless steel alloys, platinum, platinum iridium, and mixturesthereof.
 106. The implantable cardioverter-defibrillator of claim 61,wherein the second electrode is substantially planar.
 107. Theimplantable cardioverter-defibrillator of claim 61, wherein the secondelectrode comprises a substantially flat sheet of metallic material.108. The implantable cardioverter-defibrillator of claim 107, whereinthe metallic material is selected from the group consisting essentiallyof titanium, nickel alloys, stainless steel alloys, platinum, platinumiridium, and mixtures thereof.
 109. The implantablecardioverter-defibrillator of claim 61, wherein the lead electrodeassembly further comprises a lead coupled between the housing and thesecond electrode.
 110. The implantable cardioverter-defibrillator ofclaim 109, wherein the lead comprises one or more electrical conductorselectrically coupled to the second electrode.
 111. The implantablecardioverter-defibrillator of claim 110, wherein the lead furthercomprises an electrically insulating sheath enclosing the one or moreelectrical conductors.
 112. The implantable cardioverter-defibrillatorof claim 109, wherein the lead electrode assembly further comprises aconnector coupled to the lead.
 113. The implantablecardioverter-defibrillator of claim 112, wherein the connector iselectrically coupled to the second electrode.
 114. The implantablecardioverter-defibrillator of claim 109, wherein the lead is betweenapproximately 5 cm and approximately 52 cm in length.
 115. Theimplantable cardioverter-defibrillator of claim 114, wherein the lead isbetween approximately 5 cm and approximately 30 cm in length.
 116. Theimplantable cardioverter-defibrillator of claim 115, wherein the lead isbetween approximately 10 cm and approximately 20 cm in length.
 117. Theimplantable cardioverter-defibrillator of claim 114, wherein the leadlength is one of a plurality of preset lengths.
 118. The implantablecardioverter-defibrillator of claim 117, wherein the pre-set lengthsvary by approximately 10 cm.
 119. The implantablecardioverter-defibrillator of claim 109, wherein the lead has a proximalend and a distal end and wherein the proximal end of the lead is coupledto the second electrode.
 120. The implantable cardioverter-defibrillatorof claim 119, wherein the lead electrode assembly further comprises alead fastener coupled between the lead and the second electrode.
 121. Alead electrode assembly for subcutaneous implantation in a patient'sposterior thorax from an incision in the skin covering the patient'santerior thorax comprising an electrode.
 122. The lead electrodeassembly of claim 121, wherein the electrode can emit an effectiveenergy for shocking the patient's heart.
 123. The lead electrodeassembly of claim 122, wherein the effective energy for shocking thepatient's heart is approximately 25 J to approximately 50 J.
 124. Thelead electrode assembly of claim 122, wherein the effective energy forshocking the patient's heart is approximately 50 J to approximately 75J.
 125. The lead electrode assembly of claim 122, wherein the effectiveenergy for shocking the patient's heart is approximately 75 J toapproximately 100 J.
 126. The lead electrode assembly of claim 122,wherein the effective energy for shocking the patient's heart isapproximately 100 J to approximately 125 J.
 127. The lead electrodeassembly of claim 122, wherein the effective energy for shocking thepatient's heart is approximately 125 J to approximately 150 J.
 128. Thelead electrode assembly of claim 122, wherein the effective energy forshocking the patient's heart is approximately 150 J.
 129. The leadelectrode assembly of claim 122, wherein the electrode can furtherreceive physiological information from the patient through sensors. 130.The lead electrode assembly of claim 121, wherein the electrode canreceive physiological information from the patient through sensors. 131.The lead electrode assembly of claim 121, wherein at least a portion ofthe electrode is non-planar.
 132. The lead electrode assembly of claim121, wherein the electrode is substantially ellipsoidal in shape. 133.The lead electrode assembly of claim 121, wherein the electrode issubstantially thumbnail shaped.
 134. The lead electrode assembly ofclaim 121, wherein the electrode is substantially circular in shape.135. The lead electrode assembly of claim 121, wherein the electrode issubstantially square in shape.
 136. The lead electrode assembly of claim135, wherein the electrode comprises rounded corners.
 137. The leadelectrode assembly of claim 121, wherein the electrode is substantiallyrectangular in shape.
 138. The lead electrode assembly of claim 137,wherein the electrode comprises rounded corners.
 139. The lead electrodeassembly of claim 121, wherein the electrode is substantially triangularin shape.
 140. The lead electrode assembly of claim 139, wherein theelectrode comprises rounded corners.
 141. The lead electrode assembly ofclaim 121, wherein the electrode is less than approximately 1000 squaremillimeters in area.
 142. The lead electrode assembly of claim 141,wherein the electrode is between approximately 750 square millimeters toapproximately 1000 square millimeters in area.
 143. The lead electrodeassembly of claim 142, wherein the electrode is between approximately500 square millimeters to approximately 750 square millimeters in area.144. The lead electrode assembly of claim 121, wherein the electrode isbetween approximately 250 square millimeters to approximately 500 squaremillimeters in area.
 145. The lead electrode assembly of claim 121,wherein the electrode is between approximately 100 square millimeters toapproximately 250 square millimeters in area.
 146. The lead electrodeassembly of claim 121, wherein the electrode is positioned approximatelyin a posterior region of the patient's ribcage.
 147. The lead electrodeassembly of claim 121, wherein the electrode is positioned approximatelyin a paraspinal region of the patient.
 148. The lead electrode assemblyof claim 121, wherein the electrode is positioned approximately in aparascapular region of the patient.
 149. The lead electrode assembly ofclaim 121, wherein the electrode is positioned approximately posteriorto a mid axillary line of the patient.
 150. The lead electrode assemblyof claim 121, wherein the electrode is positioned approximatelyposterior and lateral to an anterior axillary line of the patient. 151.The lead electrode assembly of claim 121, wherein lead electrodeassembly further comprises a backing layer coupled to the electrode.152. The lead electrode assembly of claim 151, wherein the backing layercomprises a polymeric material.
 153. The lead electrode assembly ofclaim 152, wherein the polymeric material is selected from the groupconsisting essentially of a polyurethane, a polyamide, apolyetheretherketone (PEEK), a polyether block amide (PEBA), apolytetrafluoroethylene (PTFE), a silicone, and mixtures thereof. 154.The lead electrode assembly of claim 151, wherein the backing layer issubstantially planar.
 155. The lead electrode assembly of claim 154,wherein the backing layer is substantially parallel to the electrode.156. The lead electrode assembly of claim 121, wherein at least aportion of the electrode is covered by a skirt.
 157. The lead electrodeassembly of claim 121, wherein the lead electrode assembly furthercomprises a molded cover coupled to the electrode.
 158. The leadelectrode assembly of claim 157, wherein the molded cover partiallycovers the eletoctrode
 159. The lead electrode assembly of claim 158,wherein the molded cover comprises a skirt that partially covers abottom surface of the electrode.
 160. The lead electrode assembly ofclaim 157, wherein the molded cover comprises a polymeric material. 161.The lead electrode assembly of claim 160, wherein the polymeric materialis selected from the group consisting essentially of a polyurethane, apolyamide, a polyetheretherketone (PEEK), a polyether block amide(PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixturesthereof.
 162. The lead electrode assembly of claim 121, wherein theelectrode comprises a mesh of metallic material.
 163. The lead electrodeassembly of claim 162, wherein the metallic material is selected fromthe group consisting essentially of titanium, nickel alloys, stainlesssteel alloys, platinum, platinum iridium, and mixtures thereof.
 164. Thelead electrode assembly of claim 121, wherein the electrode comprises ametallic material.
 165. The lead electrode assembly of claim 164,wherein the metallic material is selected from the group consistingessentially of titanium, nickel alloys, stainless steel alloys,platinum, platinum iridium, and mixtures thereof.
 166. The leadelectrode assembly of claim 121, wherein the electrode is substantiallyplanar.
 167. The lead electrode assembly of claim 121, wherein theelectrode comprises a substantially flat sheet of metallic material.168. The lead electrode assembly of claim 167, wherein the metallicmaterial is selected from the group consisting essentially of titanium,nickel alloys, stainless steel alloys, platinum, platinum iridium, andmixtures thereof.
 169. The lead electrode assembly of claim 121, whereinthe lead electrode assembly further comprises a lead coupled to theelectrode.
 170. The lead electrode assembly of claim 169, wherein thelead comprises one or more electrical conductors electrically coupled tothe electrode.
 171. The lead electrode assembly of claim 170, whereinthe lead further comprises an electrically insulating sheath enclosingthe one or more electrical conductors.
 172. The lead electrode assemblyof claim 169, wherein the lead electrode assembly further comprises aconnector coupled to the lead.
 173. The lead electrode assembly of claim172, wherein the connector is electrically coupled to the electrode.174. The lead electrode assembly of claim 169, wherein the lead isbetween approximately 5 cm and approximately 52 cm in length.
 175. Thelead electrode assembly of claim 174, wherein the lead is betweenapproximately 5 cm and approximately 30 cm in length.
 176. The leadelectrode assembly of claim 175, wherein the lead is betweenapproximately 10 cm and approximately 20 cm in length.
 177. The leadelectrode assembly of claim 174, wherein the lead length is one of aplurality of pre-set lengths.
 178. The lead electrode assembly of claim177, wherein the pre-set lengths vary by approximately 10 cm.
 179. Thelead electrode assembly of claim 169, wherein the lead has a proximalend and a distal end and wherein the proximal end of the lead is coupledto the electrode.
 180. The lead electrode assembly of claim 179, whereinthe lead electrode assembly further comprises a lead fastener coupledbetween the lead and the electrode.
 181. An implantablecardioverter-defibrillator for subcutaneous positioning between thethird rib and the twelfth rib within a patient, the implantablecardioverter-defibrillator comprising: a housing; and a lead electrodeassembly coupled to the housing, wherein the lead electrode assemblycomprises: an electrode.
 182. The implantable cardioverter-defibrillatorof claim 181, wherein the electrode can emit an effective energy forshocking the patient's heart.
 183. The implantablecardioverter-defibrillator of claim 182, wherein the effective energyfor shocking the patient's heart is approximately 25 J to approximately50 J.
 184. The implantable cardioverter-defibrillator of claim 182,wherein the effective energy for shocking the patient's heart isapproximately 50 J to approximately 75 J.
 185. The implantablecardioverter-defibrillator of claim 182, wherein the effective energyfor shocking the patient's heart is approximately 75 J to approximately100 J.
 186. The implantable cardioverter-defibrillator of claim 182,wherein the effective energy for shocking the patient's heart isapproximately 100 J to approximately 125 J.
 187. The implantablecardioverter-defibrillator of claim 182, wherein the effective energyfor shocking the patient's heart is approximately 125 J to approximately150 J.
 188. The implantable cardioverter-defibrillator of claim 182,wherein the effective energy for shocking the patient's heart isapproximately 150 J.
 189. The implantable cardioverter-defibrillator ofclaim 182, wherein the electrode can further receive physiologicalinformation from the patient through sensors.
 190. The implantablecardioverter-defibrillator of claim 181, wherein the electrode canreceive physiological information from the patient through sensors. 191.The implantable cardioverter-defibrillator of claim 181, wherein atleast a portion of the electrode is non-planar.
 192. The implantablecardioverter-defibrillator of claim 181, wherein the electrode issubstantially ellipsoidal in shape.
 193. The implantablecardioverter-defibrillator of claim 181, wherein the electrode issubstantially thumbnail shaped.
 194. The implantablecardioverter-defibrillator of claim 181, wherein the electrode issubstantially circular in shape.
 195. The implantablecardioverter-defibrillator of claim 181, wherein the electrode issubstantially square in shape.
 196. The implantablecardioverter-defibrillator of claim 195, wherein the electrode comprisesrounded corners.
 197. The implantable cardioverter-defibrillator ofclaim 181, wherein the electrode is substantially rectangular in shape.198. The implantable cardioverter-defibrillator of claim 197, whereinthe electrode comprises rounded corners.
 199. The implantablecardioverter-defibrillator of claim 181, wherein the electrode issubstantially triangular in shape.
 200. The implantablecardioverter-defibrillator of claim 199, wherein the electrode comprisesrounded corners.
 201. The implantable cardioverter-defibrillator ofclaim 181, wherein the electrode is less than approximately 1000 squaremillimeters in area.
 202. The implantable cardioverter-defibrillator ofclaim 201, wherein the electrode is between approximately 750 squaremillimeters to approximately 1000 square millimeters in area.
 203. Theimplantable cardioverter-defibrillator of claim 202, wherein theelectrode is between approximately 500 square millimeters toapproximately 750 square millimeters in area.
 204. The implantablecardioverter-defibrillator of claim 181, wherein the electrode isbetween approximately 250 square millimeters to approximately 500 squaremillimeters in area.
 205. The implantable cardioverter-defibrillator ofclaim 181, wherein the electrode is between approximately 100 squaremillimeters to approximately 250 square millimeters in area.
 206. Theimplantable cardioverter-defibrillator of claim 181, wherein theelectrode is positioned approximately in a posterior region of thepatient's ribcage.
 207. The implantable cardioverter-defibrillator ofclaim 181, wherein the electrode is positioned approximately in aparaspinal region of the patient.
 208. The implantablecardioverter-defibrillator of claim 181, wherein the electrode ispositioned approximately in a parascapular region of the patient. 209.The implantable cardioverter-defibrillator of claim 181, wherein theelectrode is positioned approximately posterior to a mid axillary lineof the patient.
 210. The implantable cardioverter-defibrillator of claim181, wherein the electrode is positioned approximately posterior andlateral to an anterior axillary line of the patient.
 211. Theimplantable cardioverter-defibrillator of claim 181, wherein leadelectrode assembly further comprises a backing layer coupled to theelectrode.
 212. The implantable cardioverter-defibrillator of claim 211,wherein the backing layer comprises a polymeric material.
 213. Theimplantable cardioverter-defibrillator of claim 212, wherein thepolymeric material is selected from the group consisting essentially ofa polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyetherblock amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, andmixtures thereof.
 214. The implantable cardioverter-defibrillator ofclaim 211, wherein the backing layer is substantially planar.
 215. Theimplantable cardioverter-defibrillator of claim 214, wherein the backinglayer is substantially parallel to the electrode.
 216. The implantablecardioverter-defibrillator of claim 181, wherein at least a portion ofthe electrode is covered by a skirt.
 217. The implantablecardioverter-defibrillator of claim 181, wherein the lead electrodeassembly further comprises a molded cover coupled to the electrode. 218.The implantable cardioverter-defibrillator of claim 217, wherein themolded cover partially covers the electrode
 219. The implantablecardioverter-defibrillator of claim 218, wherein the molded covercomprises a skirt that partially covers a bottom surface of theelectrode.
 220. The implantable cardioverter-defibrillator of claim 217,wherein the molded cover comprises a polymeric material.
 221. Theimplantable cardioverter-defibrillator of claim 220, wherein thepolymeric material is selected from the group consisting essentially ofa polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyetherblock amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, andmixtures thereof.
 222. The implantable cardioverter-defibrillator ofclaim 181, wherein the electrode comprises a mesh of metallic material.223. The implantable cardioverter-defibrillator of claim 222, whereinthe metallic material is selected from the group consisting essentiallyof titanium, nickel alloys, stainless steel alloys, platinum, platinumiridium, and mixtures thereof.
 224. The implantablecardioverter-defibrillator of claim 181, wherein the electrode comprisesa metallic material.
 225. The implantable cardioverter-defibrillator ofclaim 224, wherein the metallic material is selected from the groupconsisting essentially of titanium, nickel alloys, stainless steelalloys, platinum, platinum iridium, and mixtures thereof.
 226. Theimplantable cardioverter-defibrillator of claim 181, wherein theelectrode is substantially planar.
 227. The implantablecardioverter-defibrillator of claim 181, wherein the electrode comprisesa substantially flat sheet of metallic material.
 228. The implantablecardioverter-defibrillator of claim 227, wherein the metallic materialis selected from the group consisting essentially of titanium, nickelalloys, stainless steel alloys, platinum, platinum iridium, and mixturesthereof.
 229. The implantable cardioverter-defibrillator of claim 181,wherein the lead electrode assembly further comprises a lead coupledbetween the electrode and the housing.
 230. The implantablecardioverter-defibrillator of claim 229, wherein the lead comprises oneor more electrical conductors electrically coupled to the electrode.231. The implantable cardioverter-defibrillator of claim 230, whereinthe lead further comprises an electrically insulating sheath enclosingthe one or more electrical conductors.
 232. The implantablecardioverter-defibrillator of claim 229, wherein the lead electrodeassembly further comprises a connector coupled to the lead.
 233. Theimplantable cardioverter-defibrillator of claim 232, wherein theconnector is electrically coupled to the electrode.
 234. The implantablecardioverter-defibrillator of claim 229, wherein the lead is betweenapproximately 5 cm and approximately 52 cm in length.
 235. Theimplantable cardioverter-defibrillator of claim 234, wherein the lead isbetween approximately 5 cm and approximately 30 cm in length.
 236. Theimplantable cardioverter-defibrillator of claim 235, wherein the lead isbetween approximately 10 cm and approximately 20 cm in length.
 237. Theimplantable cardioverter-defibrillator of claim 234, wherein the leadlength is one of a plurality of preset lengths.
 238. The implantablecardioverter-defibrillator of claim 237, wherein the pre-set lengthsvary by approximately 10 cm.
 239. The implantablecardioverter-defibrillator of claim 229, wherein the lead has a proximalend and a distal end and wherein the proximal end of the lead is coupledto the electrode.
 240. The implantable cardioverter-defibrillator ofclaim 239, wherein the lead electrode assembly further comprises a leadfastener coupled between the lead and the electrode.